Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-02 @ 12:24 PM
Study NCT ID:
NCT02037893
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2014-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000983', 'term': 'Antipyrine'}], 'ancestors': [{'id': 'D047069', 'term': 'Pyrazolones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'egould@pernixtx.com', 'phone': '8007932145', 'title': 'Senior Director, Medical and Scientific Affairs', 'organization': 'Pernix Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 120 hours after first dose', 'eventGroups': [{'id': 'EG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 6, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 9, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 4, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 5, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoacisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lice infestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '2.82', 'groupId': 'OG001'}, {'value': '-4.6', 'spread': '2.97', 'groupId': 'OG002'}, {'value': '-4.9', 'spread': '2.13', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 hour after a single dose', 'description': 'The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population'}, {'type': 'SECONDARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.6', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '0.51', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '0.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 15 min post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.'}, {'type': 'SECONDARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '-4.8', 'spread': '0.48', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 30 min post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.'}, {'type': 'SECONDARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '0.50', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '0.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 3 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.'}, {'type': 'SECONDARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '0.54', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 6 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.'}, {'type': 'SECONDARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.60', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '0.57', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '0.57', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 12 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.'}, {'type': 'SECONDARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '-4.6', 'spread': '0.46', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 24 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.'}, {'type': 'SECONDARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '-5.5', 'spread': '0.45', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 36 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.'}, {'type': 'SECONDARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.4', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '-5.9', 'spread': '0.40', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 48 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.'}, {'type': 'SECONDARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.4', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '-6.2', 'spread': '0.36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 60 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.'}, {'type': 'SECONDARY', 'title': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '-6.1', 'spread': '0.32', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 72 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'FG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'FG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Antipyrine and Benzocaine Otic Solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine and Benzocaine otic solution: antipyrine 54 mg and benzocaine 14 mg\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'BG001', 'title': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nAntipyrine Otic Solution: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'BG002', 'title': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nBenzocaine Otic Solution: benzocaine 14 mg and glycerine dehydrated to 1.0 mL\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping\n\nPlacebo Otic solution: Placebo otic solution will be glycerin that is dehydrated'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '3.27', 'groupId': 'BG000'}, {'value': '4.4', 'spread': '3.36', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '3.75', 'groupId': 'BG002'}, {'value': '3.5', 'spread': '3.35', 'groupId': 'BG003'}, {'value': '4.2', 'spread': '3.41', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2014-01-13', 'resultsFirstSubmitDate': '2018-07-03', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-01', 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)', 'timeFrame': 'Baseline and 1 hour after a single dose', 'description': 'The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}], 'secondaryOutcomes': [{'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose', 'timeFrame': 'Change from Baseline to 15 min post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}, {'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose', 'timeFrame': 'Change from Baseline to 30 min post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}, {'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose', 'timeFrame': 'Change from Baseline to 3 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}, {'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose', 'timeFrame': 'Change from Baseline to 6 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}, {'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose', 'timeFrame': 'Change from Baseline to 12 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}, {'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose', 'timeFrame': 'Change from Baseline to 24 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}, {'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose', 'timeFrame': 'Change from Baseline to 36 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}, {'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose', 'timeFrame': 'Change from Baseline to 48 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}, {'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose', 'timeFrame': 'Change from Baseline to 60 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}, {'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose', 'timeFrame': 'Change from Baseline to 72 hour post first dose', 'description': 'The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.\n\nThe FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.\n\nThe FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Otitis Media']}, 'descriptionModule': {'briefSummary': 'The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.', 'detailedDescription': 'Reduction of pain symptoms will be measured by using the Face, Legs, Activity, Cry, Consolability Scale (FLACC) and the Faces pain Scale Revised (FPS-R).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Diagnosis of Acute Otitis Media\n* Moderate to severe pain\n* Normally active and in good health as determined by the PI\n* Parent or legal guardian consent\n* Caregiver available to complete diaries during study\n\nExclusion Criteria:\n\n* History of or current Perforated tympanic membrane\n* Tympanostomy tubes\n* Acute or chronic otitis externa\n* seborrheic dermatitis\n* Received any otic topical or systemic antibiotic within 14 days of enrollment\n* Receiving medication on a chronic basis for pain\n* Known hypersensitivity to investigational product.\n* clinical significant mental illness as determined by the PI\n* Exposed to another investigational agent within 30 days before study entry. Any condition the PI believed will interfere with the ability to comply with all study procedures\n* History of glucose 6-phosphate dehydrogenase deficiency\n* History or currently anemic\n* Congenital methemoglobinemia\n* Recent history of acute gastroenteritis within 14 days of enrollment'}, 'identificationModule': {'nctId': 'NCT02037893', 'briefTitle': 'Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media', 'organization': {'class': 'INDUSTRY', 'fullName': 'Currax Pharmaceuticals'}, 'officialTitle': 'A Four-arm, Randomized, Double-blind, Active and Placebo Controlled Study to Determine the Safety and Efficacy of a Combination Antipyrine and Benzocaine Otic Solution Compared With Antipyrine Otic Solution Alone, Benzocaine Otic Solution Alone and to Placebo Otic Solution to Relieve Pain Symptoms in Children With Acute Otitis Media.', 'orgStudyIdInfo': {'id': 'PNX-CL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antipyrine and Benzocaine Otic solution', 'description': 'antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping', 'interventionNames': ['Drug: Antipyrine and Benzocaine otic solution', 'Drug: Placebo Otic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antipyrine Otic Solution', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping', 'interventionNames': ['Drug: Antipyrine Otic Solution', 'Drug: Placebo Otic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Benzocaine Otic Solution', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping', 'interventionNames': ['Drug: Benzocaine Otic Solution', 'Drug: Placebo Otic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping', 'interventionNames': ['Drug: Placebo Otic solution']}], 'interventions': [{'name': 'Antipyrine and Benzocaine otic solution', 'type': 'DRUG', 'description': 'antipyrine 54 mg and benzocaine 14 mg', 'armGroupLabels': ['Antipyrine and Benzocaine Otic solution']}, {'name': 'Antipyrine Otic Solution', 'type': 'DRUG', 'description': 'Antipyrine 54 mg and glycerine dehydrated to 1.0 mL', 'armGroupLabels': ['Antipyrine Otic Solution']}, {'name': 'Benzocaine Otic Solution', 'type': 'DRUG', 'description': 'benzocaine 14 mg and glycerine dehydrated to 1.0 mL', 'armGroupLabels': ['Benzocaine Otic Solution']}, {'name': 'Placebo Otic solution', 'type': 'DRUG', 'description': 'Placebo otic solution will be glycerin that is dehydrated', 'armGroupLabels': ['Antipyrine Otic Solution', 'Antipyrine and Benzocaine Otic solution', 'Benzocaine Otic Solution', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Desert Clinical Research', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72712', 'city': 'Bentonville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Childrens Investigational Research Program', 'geoPoint': {'lat': 36.37285, 'lon': -94.20882}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Pediatric and Adult Research', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '29118', 'city': 'Orangeburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Ear, Nose and Throat Clinic', 'geoPoint': {'lat': 33.49182, 'lon': -80.85565}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Foothill Family Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'FirstMed East', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Jordan River Family Medicine', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}], 'overallOfficials': [{'name': 'Steven Goldberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Visions Clinical Research'}, {'name': 'Gerald Shockey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Desert Clinical Research'}, {'name': 'Shane Christensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foothill Family Clinic South'}, {'name': 'Stephanie Plunkett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Med East'}, {'name': 'Katie Julien, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordan River Family Medcine'}, {'name': 'James Peterson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foothill Family Clinic'}, {'name': 'John Ansely, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolina Ear, Nose and Throat Clinic'}, {'name': 'James Hendrick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kentucky Pediatric and Adult Research'}, {'name': 'Amy Agua, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Visions Clinical Research Boyton Beach'}, {'name': 'Bryan Harvey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Childrens Investigational Research Program'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Currax Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}