Ignite Creation Date:
2025-12-17 @ 3:12 PM
Ignite Modification Date:
2025-12-23 @ 10:36 PM
Study NCT ID:
NCT00787566
Status:
COMPLETED
Last Update Posted:
2011-07-12
First Post:
2008-11-05
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vvragavan@comcast.net', 'phone': '610-795-7403', 'title': 'Vanaja V. Ragavan, M.D.', 'organization': 'Aviana Consulting, LLC'}, 'certainAgreement': {'otherDetails': 'SNBL and investigators agreed that SNBL would retain the exclusive right to disseminate data arising from the study through either publication or presentation, including study results, and that SNBL would retain exclusive editorial rights over manuscripts or presentations.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Dosing of study drug through safety follow-up period (maximum 38 days)', 'description': 'Telephone questioning 2-24 hours after start of chemotherapy; 8 day patient diary', 'eventGroups': [{'id': 'EG000', 'title': '0.5 mg of TRG (Intranasal Granisetron)', 'description': '0.5 mg dose, intranasal powder, single spray, administered once', 'otherNumAtRisk': 21, 'otherNumAffected': 16, 'seriousNumAtRisk': 21, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '1.0 mg of TRG (Intranasal Granisetron)', 'description': '1.0 mg dose, intranasal powder, single spray, administered once', 'otherNumAtRisk': 25, 'otherNumAffected': 16, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '2.0 mg of TRG (Intranasal Granisetron)', 'description': '2.0 mg dose, intranasal powder, single spray, administered once', 'otherNumAtRisk': 22, 'otherNumAffected': 15, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Dehydration', 'notes': 'Not related to study mediation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypotension', 'notes': 'Not related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Non-small cell lung cancer metastatic', 'notes': 'Not related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pancytopenia', 'notes': 'Not related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutropenia', 'notes': 'Not related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'notes': 'Not related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sepsis', 'notes': 'Not related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tachycardia', 'notes': 'Not related to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Complete Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mg of TRG (Intranasal Granisetron)', 'description': '0.5 mg dose, intranasal powder, single spray, administered once'}, {'id': 'OG001', 'title': '1.0 mg of TRG (Intranasal Granisetron)', 'description': '1.0 mg dose, intranasal powder, single spray, administered once'}, {'id': 'OG002', 'title': '2.0 mg of TRG (Intranasal Granisetron)', 'description': '2.0 mg dose, intranasal powder, single spray, administered once'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '76.0', 'groupId': 'OG001'}, {'value': '90.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Complete Control is defined as no emetic episodes, no use of rescue medications, and no more than mild nausea as defined by a categorial scale.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complete Response', 'timeFrame': '24 hours', 'description': 'Complete Response is defined as no emetic episodes and no use of rescue medications', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Total Response', 'timeFrame': '24 hours', 'description': 'Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Major Control of Emesis', 'timeFrame': '24 hrs', 'description': 'Major Control of emesis = 2 emetic episodes', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Minor Control of Emesis', 'timeFrame': '24 hrs', 'description': 'Minor Control of emesis: 3-5 emetic episodes', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Failure', 'timeFrame': '24 hrs', 'description': 'Failure: \\> 5 emetic episodes', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Using Rescue Medications', 'timeFrame': '24 hours', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Emetic Episode', 'timeFrame': '24 hours', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Rescue Medication', 'timeFrame': '24 hours', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure', 'timeFrame': '24 hours', 'description': 'Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Emetic Episodes', 'timeFrame': '24 hours', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Nausea Measured by a 4 Categorical Scale', 'timeFrame': '24 hours', 'description': '4 categorical scale: none, mild (did not interfere with normal daily life), moderate (interfered with normal daily life), and severe (bedridden due to nausea/ required the patient to be bedridden)', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS', 'timeFrame': '24 hours', 'description': 'VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.5 mg of TRG (Intranasal Granisetron)', 'description': '0.5 mg dose, intranasal powder, single spray, administered once'}, {'id': 'FG001', 'title': '1.0 mg of TRG (Intranasal Granisetron)', 'description': '1.0 mg dose, intranasal powder, single spray, administered once'}, {'id': 'FG002', 'title': '2.0 mg of TRG (Intranasal Granisetron)', 'description': '2.0 mg dose, intranasal powder, single spray, administered once'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'comment': '1 patient withdrew from the study due to an AE related to chemotherapy agent administration.', 'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'AE related to chemotherapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '0.5 mg of TRG (Intranasal Granisetron)', 'description': '0.5 mg dose, intranasal powder, single spray, administered once'}, {'id': 'BG001', 'title': '1.0 mg of TRG (Intranasal Granisetron)', 'description': '1.0 mg dose, intranasal powder, single spray, administered once'}, {'id': 'BG002', 'title': '2.0 mg of TRG (Intranasal Granisetron)', 'description': '2.0 mg dose, intranasal powder, single spray, administered once'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '60.0', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '61.0', 'spread': '12.0', 'groupId': 'BG002'}, {'value': '58.9', 'spread': '12.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-05', 'studyFirstSubmitDate': '2008-11-05', 'resultsFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2008-11-06', 'lastUpdatePostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-24', 'studyFirstPostDateStruct': {'date': '2008-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Complete Control', 'timeFrame': '24 hours', 'description': 'Complete Control is defined as no emetic episodes, no use of rescue medications, and no more than mild nausea as defined by a categorial scale.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Complete Response', 'timeFrame': '24 hours', 'description': 'Complete Response is defined as no emetic episodes and no use of rescue medications'}, {'measure': 'Percentage of Patients With Total Response', 'timeFrame': '24 hours', 'description': 'Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications'}, {'measure': 'Percentage of Patients With Major Control of Emesis', 'timeFrame': '24 hrs', 'description': 'Major Control of emesis = 2 emetic episodes'}, {'measure': 'Percentage of Patients With Minor Control of Emesis', 'timeFrame': '24 hrs', 'description': 'Minor Control of emesis: 3-5 emetic episodes'}, {'measure': 'Percentage of Patients With Failure', 'timeFrame': '24 hrs', 'description': 'Failure: \\> 5 emetic episodes'}, {'measure': 'Percentage of Patients Using Rescue Medications', 'timeFrame': '24 hours'}, {'measure': 'Time to First Emetic Episode', 'timeFrame': '24 hours'}, {'measure': 'Time to First Rescue Medication', 'timeFrame': '24 hours'}, {'measure': 'Time to Treatment Failure', 'timeFrame': '24 hours', 'description': 'Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first'}, {'measure': 'Number of Emetic Episodes', 'timeFrame': '24 hours'}, {'measure': 'Severity of Nausea Measured by a 4 Categorical Scale', 'timeFrame': '24 hours', 'description': '4 categorical scale: none, mild (did not interfere with normal daily life), moderate (interfered with normal daily life), and severe (bedridden due to nausea/ required the patient to be bedridden)'}, {'measure': 'Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS', 'timeFrame': '24 hours', 'description': 'VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied'}]}, 'conditionsModule': {'keywords': ['Highly emetogenic chemotherapy induced nausea and vomiting'], 'conditions': ['Chemotherapy-Induced Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'Brief Summary: A randomized, single administration, double-blind, parallel- group Phase 2 dose finding study to assess the efficacy, tolerability, and safety of TRG in patients with chemotherapy-induced nausea and vomiting (CINV) associated with the administration of highly emetogenic chemotherapy.\n\nPrimary Objective: To select a dose for Phase 3 by assessing the efficacy, safety, and tolerability of 3 doses of TRG in patients with CINV associated with the administration of highly emetogenic chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with histologically and/or cytologically confirmed cancer\n* ECOG performance status of 0, 1, or 2\n* Patients with life expectancy of at least 3 months\n* Patients who are chemotherapy naïve\n* Patients who will be receiving the first cycle of a highly emetogenic regimen according to the MASCC criteria or the Hesketh criteria\n* Patients with adequate metabolic or hematologic values for chemotherapy\n* Patients with intact nasal mucosa\n* Non child-bearing potential patients\n* Patients able to read and write at a competent level, and capable of giving legal consent\n* Patients who have provided written informed consent\n\nExclusion Criteria:\n\n* Patients who do not receive a chemotherapy regimen which is a highly emetogenic chemotherapy regimen according to the MASCC or the Hesketh criteria\n* Patients with nasal cancers, pharyngeal cancers, maxillary sinus cancers, or ethmoid sinus cancers\n* Patients with nasal ulcers, septal perforation, or other nasal conditions that may interfere with IN administration\n* Patients with any episode of retching, vomiting, or uncontrolled nausea within 48 hours before dosing with TRG and/or administration of chemotherapy\n* Patients who have received radiation therapy in the 14 days before dosing with TRG, or for whom radiation therapy is scheduled during the 7 days after a TRG dose\n* Patients who have received any investigational product within 30 days prior to study entry\n* Patients who have received any drug or who were scheduled to receive any drug with antiemetic efficacy within 24 hours of the start of treatment\n* Patients who have an allergy or hypersensitivity to granisetron or other selective 5hydroxytryptamine3(5-HT3) receptor antagonists\n* Patients with ECOG performance status of 3 or 4\n* Patients who have or have a history of brain tumors, head cancers, or neck cancers\n* Patients who have a psychological problem that, in the Investigator's opinion, is severe enough to interfere with study eligibility or with interpretation of study results\n* Patients who are pregnant (urine test) or breastfeeding\n* Patients who have received prior cytotoxic chemotherapy given for the treatment of cancer\n* Patients scheduled to receive multiple day chemotherapy\n* Patients with clinically relevant abnormal laboratory values at the discretion of the Investigator\n* Patients with clinically relevant hepatic, renal, infectious, neurological, or psychiatric disorders, or any other major systemic illness at the discretion of the Investigator\n* Patients with any prevalence or cause of nausea and vomiting other than chemotherapy\n* Patients using systemic steroids for any indication, or patients using steroids other than dexamethasone for prevention of chemotherapy-induced nausea and vomiting, or patients using dexamethasone for chemotherapy-induced nausea and vomiting at doses other than recommended in the MASCC antiemetic guidelines\n* Patients with a QT interval greater than 500 ms or with acute ischemic changes or cardiac abnormality predisposing to arrhythmia on screening electrocardiogram (ECG) or by history\n* Patients with a history of drug and/or alcohol abuse."}, 'identificationModule': {'nctId': 'NCT00787566', 'briefTitle': 'Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shin Nippon Biomedical Laboratories, Ltd.'}, 'officialTitle': 'A Randomized, Single Administration, Double-blind, Parallel-group Phase 2 Dose Finding Study to Assess the Efficacy, Tolerability, and Safety of TRG (Intranasal Granisetron) in Patients With Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Highly Emetogenic Chemotherapy', 'orgStudyIdInfo': {'id': 'TRG-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.5 mg of TRG (intranasal granisetron)', 'description': '0.5 mg dose, intranasal powder, single spray, administered once', 'interventionNames': ['Drug: Intranasal granisetron']}, {'type': 'EXPERIMENTAL', 'label': '1.0 mg of TRG (intranasal granisetron)', 'description': '1.0 mg dose, intranasal powder, songle spray, administered once', 'interventionNames': ['Drug: Intranasal granisetron']}, {'type': 'EXPERIMENTAL', 'label': '2.0 mg of TRG (intranasal granisetron)', 'description': '2.0 mg dose, intranasal powder, single spray, administered once', 'interventionNames': ['Drug: Intranasal granisetron']}], 'interventions': [{'name': 'Intranasal granisetron', 'type': 'DRUG', 'otherNames': ['TRG'], 'description': '0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen', 'armGroupLabels': ['0.5 mg of TRG (intranasal granisetron)', '1.0 mg of TRG (intranasal granisetron)', '2.0 mg of TRG (intranasal granisetron)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28405', 'city': 'The Study Is Managed by Kendle International, in Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The study is conducted at 14 Centers, in 14 cities accross the United States'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shin Nippon Biomedical Laboratories, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Vanaja Ragavan, MD', 'oldOrganization': 'Aviana Consulting, LLC'}}}}