Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-24 @ 10:33 PM
Study NCT ID:
NCT03080493
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D002266', 'term': 'Carboxymethylcellulose Sodium'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008747', 'term': 'Methylcellulose'}, {'id': 'D002482', 'term': 'Cellulose'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010666', 'term': 'Phenylpropionates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdcreinin@ucdavis.edu', 'phone': '916-734-6670', 'title': 'Mitchell Creinin, MD', 'organization': 'University of California, Davis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'One day (from treatment initiation until procedure the following day', 'description': 'Only adverse events collected were specific to the intervention: dizziness and tiredness', 'eventGroups': [{'id': 'EG000', 'title': 'Gabapentin', 'description': 'Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nGabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 57, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Oral Capsule', 'description': 'Matched placebo\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nPlacebo oral capsule: Packaged identical to gabapentin dosing\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 51, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness at baseline', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness at 5 minutes after dilator placement', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizzines at 2 hours after dilator placement', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness at 4 hours after dilator placement', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness at 8 hours after dilator placement', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness at 18-24 hours after dilator placement', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredness at baseline', 'notes': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredness at 5 minutes after dilator placement', 'notes': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredness at 2 hours after dilator placement', 'notes': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredness at 4 hours after dilator placement', 'notes': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredness at 8 hours after dilator placement', 'notes': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredness at 18-24 hours after dilator placment', 'notes': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nGabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Matched placebo\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nPlacebo oral capsule: Packaged identical to gabapentin dosing\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '8'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 hours after insertion of last osmotic dilator', 'description': 'Pain score based on numeric rating scale (NRS \\[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.', 'unitOfMeasure': 'Numeric rating scale pain score change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who responded with pain scores by text using Numeric Rating Scale'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nGabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Matched placebo\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nPlacebo oral capsule: Packaged identical to gabapentin dosing\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '10'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 minutes after insertion of last osmotic dilator', 'description': 'Pain score based on numeric rating scale (NRS \\[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person before subject leaves clinic appointment.', 'unitOfMeasure': 'Numeric rating scale pain score change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who provided Numeric rating scale pain score'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nGabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Matched placebo\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nPlacebo oral capsule: Packaged identical to gabapentin dosing\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '9'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 hours after insertion of last osmotic dilator', 'description': 'Pain score based on numeric rating scale (NRS \\[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.', 'unitOfMeasure': 'Numeric rating scale pain score change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who responded by text with numeric pain scale score'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nGabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Matched placebo\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nPlacebo oral capsule: Packaged identical to gabapentin dosing\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '9'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours after insertion of last osmotic dilator', 'description': 'Pain score based on numeric rating scale (NRS \\[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.', 'unitOfMeasure': 'Numeric rating scale pain score change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who responded by text with numeric pain scale score'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nGabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Matched placebo\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nPlacebo oral capsule: Packaged identical to gabapentin dosing\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '7'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time of presentation for D&E (day after dilator insertion)', 'description': 'Pain score based on numeric rating scale (NRS \\[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person upon presentation for D\\&E procedure.', 'unitOfMeasure': 'Numeric rating scale pain score change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who provided numeric pain scale scores'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nGabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Matched placebo\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nPlacebo oral capsule: Packaged identical to gabapentin dosing\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure)', 'description': 'Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Any use of narcotics'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gabapentin', 'description': 'Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nGabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}, {'id': 'FG001', 'title': 'Placebo Oral Capsule', 'description': 'Matched placebo\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nPlacebo oral capsule: Packaged identical to gabapentin dosing\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Did not provide NRS pain results', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Randomization error (parity group)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gabapentin', 'description': 'Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nGabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}, {'id': 'BG001', 'title': 'Placebo Oral Capsule', 'description': 'Matched placebo\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight\n\nPlacebo oral capsule: Packaged identical to gabapentin dosing\n\nacetaminophen/codeine and ibuprofen: Over the counter analgesic medications'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '27.2', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '26.2', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Mixed', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Declined', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Reasons for abortion', 'classes': [{'categories': [{'title': 'Unwanted pregnancy', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Fetal anomalies', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Not completed high school', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'High school or equivalent', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Some college', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'College or higher', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Declined', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-11', 'size': 283930, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-28T12:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo controlled trial, stratified block randomization based on prior vaginal parity (vaginal parity - yes or no). Goal of even distribution of prior vaginal parity between gabapentin and placebo groups as may impact osmotic dilator pain experience'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2017-03-09', 'resultsFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2017-03-14', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-06', 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion', 'timeFrame': '8 hours after insertion of last osmotic dilator', 'description': 'Pain score based on numeric rating scale (NRS \\[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion', 'timeFrame': '5 minutes after insertion of last osmotic dilator', 'description': 'Pain score based on numeric rating scale (NRS \\[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person before subject leaves clinic appointment.'}, {'measure': 'Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion', 'timeFrame': '2 hours after insertion of last osmotic dilator', 'description': 'Pain score based on numeric rating scale (NRS \\[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.'}, {'measure': 'Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion', 'timeFrame': '4 hours after insertion of last osmotic dilator', 'description': 'Pain score based on numeric rating scale (NRS \\[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.'}, {'measure': 'Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)', 'timeFrame': 'Time of presentation for D&E (day after dilator insertion)', 'description': 'Pain score based on numeric rating scale (NRS \\[0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain\\]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person upon presentation for D\\&E procedure.'}, {'measure': 'Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)', 'timeFrame': 'Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure)', 'description': 'Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abortion', 'Osmotic dilators', 'Gabapentin', 'Text message'], 'conditions': ['Abortion, Induced', 'Cervical Preparation', 'Pain']}, 'referencesModule': {'references': [{'pmid': '24281281', 'type': 'BACKGROUND', 'citation': 'Yan PZ, Butler PM, Kurowski D, Perloff MD. Beyond neuropathic pain: gabapentin use in cancer pain and perioperative pain. Clin J Pain. 2014 Jul;30(7):613-29. doi: 10.1097/AJP.0000000000000014.'}, {'pmid': '11966555', 'type': 'BACKGROUND', 'citation': 'Rose MA, Kam PC. Gabapentin: pharmacology and its use in pain management. Anaesthesia. 2002 May;57(5):451-62. doi: 10.1046/j.0003-2409.2001.02399.x.'}, {'pmid': '25139724', 'type': 'BACKGROUND', 'citation': 'Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.'}]}, 'descriptionModule': {'briefSummary': "Women having abortion procedures between 15 weeks 0 days and 23 weeks 6 days gestational age on the day of their procedure commonly have dilators placed in their cervix overnight before the abortion procedure. The dilators are put in during a pelvic exam in the clinic and after women go home they expand slowly overnight to open the cervix before the abortion procedure the next day. This can be a painful experience and health care providers often give women different kinds of pain medicine to help them.\n\nThe investigators are interested in whether a medicine called gabapentin, which is a non-narcotic medicine, could help. Gabapentin is approved by the U.S. Food and Drug Administration (FDA) for prevention of seizures and for treating nerve pain and doctors are also using it to decrease pain for people having surgical procedures.\n\nThe main goals of our study are to learn about:\n\n1. Women's pain experience with dilators in their cervix overnight before the abortion procedure\n2. How well gabapentin works to decrease women's pain while they have the dilators in their cervix\n\nWomen who enroll in the study will get a dose of either gabapentin or placebo (a pill with no medicine in it) before their dilators are placed in the clinic. The medication they get (gabapentin or placebo) will be chosen by chance, like flipping a coin. Neither the women in the study nor the doctors giving them the medication will know which medication they receive so the investigators can learn about their pain without being influenced by knowing which medication they take. Doctors will be able to find out which medication women got if there is an emergency or if it changes their medical care.\n\nThe investigators will communicate with women in real time overnight by text messaging to see how much pain they are having in the moment and how much pain medicine they are taking.\n\nThe investigators hypothesize that women who receive gabapentin will have a smaller increase in their pain with the dilators than women who receive placebo (a pill with no medicine in it).\n\nThe investigators' findings will help doctors understand women's pain experience with dilators better and possibly provide a new way of treating pain with gabapentin.", 'detailedDescription': 'The investigators have planned a double-blind randomized controlled trial of repeated doses of gabapentin compared to placebo for pain management during the time after dilator insertion and prior to D\\&E the subsequent day.\n\n* Participants will receive gabapentin 600 mg or placebo prior to dilator insertion\n* Pain scores will be measured via numeric rating scale (NRS) at baseline and 5 minutes after last dilator insertion while the participant is in clinic\n* Additional pain scores, side effects (specifically dizziness and sedation), and additional analgesic use will be obtained by text message while the patient is home at 2 hours, 4 hours, and 8 hours after time of dilator insertion\n* Subjects will take a second dose of study drug (either gabapentin 600 mg or placebo, concordant with their initial medication) at 8 hours after their first dose\n* Final pain score, side effect, and analgesic use assessment will occur upon presentation to the pre-operative are for D\\&E the subsequent day\n\nThere will be no change in standard insertion of osmotic dilators (hygroscopic dilators only with Lidocaine 20mL cervical anesthesia), or provision of home analgesic medications (ibuprofen and acetaminophen with codeine in our practice).\n\nThe investigators hypothesize that women who receive gabapentin will report a smaller increase in pain from baseline at 8 hours after dilator placement compared to women receiving placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 15 weeks 0 days gestational age - 23 weeks 5 days gestational age at time of dilator insertion\n* Able to read and write in English\n* Active cell phone with text messaging capability\n* Ride home from dilator insertion clinic appointment\n\nExclusion Criteria:\n\n* Current use of gabapentin or pregabalin\n* Allergy to gabapentin, acetaminophen, codeine, or ibuprofen\n* Self reported renal disease (severe impaired renal function)\n* Self reported current or chronic narcotic use (typical daily use)\n* Women with any issue that, in the opinion of the investigator, would interfere with study participation or generating accurate study data'}, 'identificationModule': {'nctId': 'NCT03080493', 'acronym': 'GABA', 'briefTitle': 'Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '987072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gabapentin', 'description': 'Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight', 'interventionNames': ['Drug: Gabapentin 600mg', 'Drug: acetaminophen/codeine and ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo oral capsule', 'description': 'Matched placebo\n\nWill receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight', 'interventionNames': ['Drug: Placebo oral capsule', 'Drug: acetaminophen/codeine and ibuprofen']}], 'interventions': [{'name': 'Gabapentin 600mg', 'type': 'DRUG', 'otherNames': ['Neurontin'], 'description': 'Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)', 'armGroupLabels': ['Gabapentin']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'otherNames': ['Carboxymethyl cellulose'], 'description': 'Packaged identical to gabapentin dosing', 'armGroupLabels': ['Placebo oral capsule']}, {'name': 'acetaminophen/codeine and ibuprofen', 'type': 'DRUG', 'otherNames': ['Tylenol-Codeine No. 3', 'Advil'], 'description': 'Over the counter analgesic medications', 'armGroupLabels': ['Gabapentin', 'Placebo oral capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Health System', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Natasha Schimmoeller, MD, MPH, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'Mitchell Creinin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Davis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}