Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-15 @ 3:30 PM
Study NCT ID:
NCT00573768
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2007-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614065', 'term': 'diclofenac diethylamine'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sandy.hamelsky@novartis.com', 'phone': '+19735037258', 'title': 'Sandy Hamelsky', 'organization': 'Novartis Consumer Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Diclofenac Diethylamine (DDEA) 2.32% Gel BID', 'description': 'Twice daily (BID) application', 'otherNumAtRisk': 89, 'otherNumAffected': 3, 'seriousNumAtRisk': 89, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DDEA 2.32% Gel OD', 'description': 'Once daily (OD) application of active gel and OD application of vehicle gel', 'otherNumAtRisk': 91, 'otherNumAffected': 6, 'seriousNumAtRisk': 91, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vehicle Gel', 'description': 'BID application', 'otherNumAtRisk': 91, 'otherNumAffected': 1, 'seriousNumAtRisk': 91, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDra 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Diethylamine (DDEA) 2.32% Gel BID', 'description': 'Twice daily (BID) application'}, {'id': 'OG001', 'title': 'DDEA 2.32% Gel OD', 'description': 'Once daily (OD) application of active gel and OD application of vehicle gel'}, {'id': 'OG002', 'title': 'Vehicle Gel', 'description': 'BID application'}], 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '20.4', 'groupId': 'OG001'}, {'value': '33.4', 'spread': '20.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline (on day 1) to day 5', 'description': 'Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diclofenac Diethylamine (DDEA) 2.32% Gel BID', 'description': 'Twice daily (BID) application'}, {'id': 'FG001', 'title': 'DDEA 2.32% Gel OD', 'description': 'Once daily (OD) application of active gel and OD application of vehicle gel'}, {'id': 'FG002', 'title': 'Vehicle Gel', 'description': 'BID application'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment start 27 Nov 2007 Recruitment end 26 Jun 2007 Private Practices'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '271', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Diclofenac Diethylamine (DDEA) 2.32% Gel BID', 'description': 'Twice daily (BID) application'}, {'id': 'BG001', 'title': 'DDEA 2.32% Gel OD', 'description': 'Once daily (OD) application of active gel and OD application of vehicle gel'}, {'id': 'BG002', 'title': 'Vehicle Gel', 'description': 'BID application'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '38.2', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '38.9', 'spread': '14.1', 'groupId': 'BG002'}, {'value': '38.6', 'spread': '14.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '271', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-18', 'studyFirstSubmitDate': '2007-12-13', 'resultsFirstSubmitDate': '2010-07-28', 'studyFirstSubmitQcDate': '2007-12-13', 'lastUpdatePostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-10-21', 'studyFirstPostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.', 'timeFrame': 'change from baseline (on day 1) to day 5', 'description': 'Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ankle, sprain, diclofenac diethylamine'], 'conditions': ['Ankle Sprain']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute sprain of the ankle\n* Injury within past 48 hours.\n\nExclusion Criteria:\n\n* Pain medication taken since the injury\n* Pain or instability in the same ankle due to previous ankle sprain or any other trauma.\n* Ankle sprain due to a known disease affecting the ligaments\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00573768', 'briefTitle': 'Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Multi-center, Vehicle-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Once or Twice Daily in Patients With Acute Ankle Sprain', 'orgStudyIdInfo': {'id': 'VOPO-PE-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Diclofenac diethylamine 2.32% gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Diclofenac diethylamine 2.32% gel / Placebo']}], 'interventions': [{'name': 'Diclofenac diethylamine 2.32% gel', 'type': 'DRUG', 'description': 'Diclofenac diethylamine 2.32% gel twice daily', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Vehicle 2 times daily', 'armGroupLabels': ['2']}, {'name': 'Diclofenac diethylamine 2.32% gel / Placebo', 'type': 'DRUG', 'description': 'Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24576', 'city': 'Bad Bramstedt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.91827, 'lon': 9.88243}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '26160', 'city': 'Bad Zwischenahn', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.18475, 'lon': 8.00286}}, {'zip': '10589', 'city': 'Berlin', 'country': 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