Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT01066520
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2010-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'istvan.zatik@heel.com', 'phone': '+4972215013192', 'title': 'Dr. Istvan Zatik', 'organization': 'Biologische Heilmittel Heel GmbH'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety information was collected for the whole duration of the trial from 24.08.2009 (FPI) to 12.09.2011 (LPO)', 'eventGroups': [{'id': 'EG000', 'title': 'Traumeel S Ointment', 'description': 'Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing', 'otherNumAtRisk': 152, 'otherNumAffected': 11, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Traumeel S Gel', 'description': 'Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing', 'otherNumAtRisk': 148, 'otherNumAffected': 15, 'seriousNumAtRisk': 148, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Diclofenac Gel', 'description': 'NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing', 'otherNumAtRisk': 147, 'otherNumAffected': 8, 'seriousNumAtRisk': 147, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharingitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoasthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oropharingeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7", 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Traumeel S Ointment', 'description': 'Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}, {'id': 'OG001', 'title': 'Traumeel S Gel', 'description': 'Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}, {'id': 'OG002', 'title': 'Diclofenac Gel', 'description': 'NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.00', 'groupId': 'OG000', 'lowerLimit': '-45.40', 'upperLimit': '-23.70'}, {'value': '-37.10', 'groupId': 'OG001', 'lowerLimit': '-50.00', 'upperLimit': '-27.30'}, {'value': '-37.10', 'groupId': 'OG002', 'lowerLimit': '-47.40', 'upperLimit': '-26.80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline (day 1) visit to day 7', 'description': 'Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.\n\nThe highest is the change in negative, the better are the results in absolute values.', 'unitOfMeasure': 'Absolute value units on a scale VAS', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Changes from baseline at day7: absolute values and in percentage. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS\\<30 mm were excluded from the analysis set. Missing data were handled by the 'Last Observation Carried Forward' method."}, {'type': 'PRIMARY', 'title': 'Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Traumeel S Ointment', 'description': 'Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}, {'id': 'OG001', 'title': 'Traumeel S Gel', 'description': 'Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}, {'id': 'OG002', 'title': 'Diclofenac Gel', 'description': 'NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}], 'classes': [{'categories': [{'measurements': [{'value': '26.20', 'groupId': 'OG000', 'lowerLimit': '16.70', 'upperLimit': '35.70'}, {'value': '26.20', 'groupId': 'OG001', 'lowerLimit': '16.70', 'upperLimit': '36.90'}, {'value': '25.00', 'groupId': 'OG002', 'lowerLimit': '14.60', 'upperLimit': '34.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to day 7', 'description': "The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.\n\nEach item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to 'unable to do' (score 0). Responses marked as ´not applicable´were not counted.\n\nItem score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Changes to Baseline: absolute values. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS\\<30 mm were excluded from the analysis set. Missing data were handled by the 'Last Observation Carried Forward' method."}, {'type': 'SECONDARY', 'title': 'FAAM ADL Subscale', 'timeFrame': 'Day 1 to 4, 14, 42', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'FAAM Sports Subscale', 'timeFrame': 'Day 1 to 4, 7, 14, 42', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': "Swelling ('Figure-of-eight')", 'timeFrame': 'Day 1 to 4,7,14', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': "Physician's Assessment of Normal Function/Activity (5-point-scale)", 'timeFrame': 'Day 1 to 4, 7, 14, 42', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Normal Function (Training/Sports)', 'timeFrame': 'Day 1 to 4, 7, 14, 42', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Global Judgment of Efficacy', 'timeFrame': 'Day 14', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': "Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7", 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Traumeel S Ointment', 'description': 'Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}, {'id': 'OG001', 'title': 'Traumeel S Gel', 'description': 'Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}, {'id': 'OG002', 'title': 'Diclofenac Gel', 'description': 'NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}], 'classes': [{'categories': [{'measurements': [{'value': '-60.55', 'groupId': 'OG000', 'lowerLimit': '-85.70', 'upperLimit': '-42.90'}, {'value': '-71.10', 'groupId': 'OG001', 'lowerLimit': '-84.85', 'upperLimit': '-48.40'}, {'value': '-68.90', 'groupId': 'OG002', 'lowerLimit': '-83.60', 'upperLimit': '-48.95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline (day 1) visit to day 7', 'description': 'Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.\n\nThe highest is the change in negative, the better are the results in percentages.', 'unitOfMeasure': 'Percentage change in scale VAS', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Traumeel S Ointment', 'description': 'Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}, {'id': 'FG001', 'title': 'Traumeel S Gel', 'description': 'Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}, {'id': 'FG002', 'title': 'Diclofenac Gel', 'description': 'NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Initiation date stage I(299 patients):24.08.2009, completion date stage I: 19.01.2011 Initiation date stage II(150 patients): 04.03.2011, completion date stage II: 12.09.2011 The evaluation criteria have not been changed in the different stages. The interim analysis after Stage I re-confirmed the originally calculated sample size.', 'preAssignmentDetails': 'Athletes of both sexes with acute unilateral sprain of the lateral ankle joint; 18 to 40 years of age; injury occurred within 24 hours of the first dose of study medication, with moderate (30-60mm) to severe (\\>60mm) pain on weight bearing.420 of the enrolled 449 patients have been selected into the ITT population. 447 patients received treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '420', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Traumeel S Ointment', 'description': 'Traumeel S Ointment 2g, 3 times daily topical during 14 days'}, {'id': 'BG001', 'title': 'Traumeel S Gel', 'description': 'Traumeel S Gel 2g, 3 times daily topical during 14 days'}, {'id': 'BG002', 'title': 'Diclofenac Gel', 'description': 'Diclofenac Gel 2g, 3 times daily topical during 14 days'}, {'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': '143', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '420', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '308', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '420', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analyzed ITT population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 449}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-09', 'studyFirstSubmitDate': '2010-02-09', 'resultsFirstSubmitDate': '2013-02-18', 'studyFirstSubmitQcDate': '2010-02-09', 'lastUpdatePostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-15', 'studyFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7", 'timeFrame': 'From baseline (day 1) visit to day 7', 'description': 'Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.\n\nThe highest is the change in negative, the better are the results in absolute values.'}, {'measure': 'Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7', 'timeFrame': 'Day 1 to day 7', 'description': "The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.\n\nEach item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to 'unable to do' (score 0). Responses marked as ´not applicable´were not counted.\n\nItem score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction."}, {'measure': "Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7", 'timeFrame': 'From baseline (day 1) visit to day 7', 'description': 'Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.\n\nThe highest is the change in negative, the better are the results in percentages.'}], 'secondaryOutcomes': [{'measure': 'FAAM ADL Subscale', 'timeFrame': 'Day 1 to 4, 14, 42'}, {'measure': 'FAAM Sports Subscale', 'timeFrame': 'Day 1 to 4, 7, 14, 42'}, {'measure': "Swelling ('Figure-of-eight')", 'timeFrame': 'Day 1 to 4,7,14'}, {'measure': "Physician's Assessment of Normal Function/Activity (5-point-scale)", 'timeFrame': 'Day 1 to 4, 7, 14, 42'}, {'measure': 'Time to Normal Function (Training/Sports)', 'timeFrame': 'Day 1 to 4, 7, 14, 42'}, {'measure': 'Global Judgment of Efficacy', 'timeFrame': 'Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ankle sprain', 'traumeel', 'diclofenac', 'antiinflammatory', 'time to normal function'], 'conditions': ['Sprain of Ankle']}, 'referencesModule': {'references': [{'pmid': '23889885', 'type': 'DERIVED', 'citation': 'Gonzalez de Vega C, Speed C, Wolfarth B, Gonzalez J. Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial. Int J Clin Pract. 2013 Oct;67(10):979-89. doi: 10.1111/ijcp.12219. Epub 2013 Jul 25.'}], 'seeAlsoLinks': [{'url': 'http://onlinelibrary.wiley.com/doi/10.1111/ijcp.12219/full', 'label': 'Primary publication paper International Journal of Clinical Practice online'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the efficacy of Traumeel S (both ointment and gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained ankle.', 'detailedDescription': 'Study objective is the confirmatory proof of efficacy for Traumeel® S topical treatment, both ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain. In addition tolerability/safety of both drug preparations is to be compared, so that the benefit-risk relation can be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Athletes with an acute unilateral ankle sprain of the lateral ligaments of the ankle joint both male and female\n* Moderate (30-60 mm) to severe (\\>60 mm) pain according to the patient's assessment of ankle pain visual analogue scale (VAS) on weight bearing, unable to perform normal training / sports activities\n* 18 - 40 years of age\n* injury occurred within 24 hours of the first dose of study medication\n* Willing and able to give written informed consent\n* Available for the duration of the study\n\nExclusion Criteria:\n\n* Similar injury affecting the same joint within the past 6 months\n* bilateral ankle injury\n* bed rest, hospitalization, surgery use of a non-removable rigid cast\n* Clinically important abnormality for screening laboratory tests\n* Debilitating acute or chronic illness\n* Use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6 hours, or 24 hours in case of long-acting NSAID, COX-2 specific inhibitors, or tramadol\n* History of sensitivity to any component of the study drugs\n* Unwilling or unable to comply with all the requirements of the protocol\n* Participation in other studies within 4 weeks prior to study entry and or during the study participation\n* Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result"}, 'identificationModule': {'nctId': 'NCT01066520', 'acronym': 'TAASS', 'briefTitle': 'TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biologische Heilmittel Heel GmbH'}, 'officialTitle': 'A Randomized, Controlled, Multi-center Study on the Effectiveness of Traumeel S (Both Ointment and Gel) in Terms of Pain and Function Compared With a Topical NSAID in Athletes With Acute Ankle Sprain', 'orgStudyIdInfo': {'id': 'TRS-ESP'}, 'secondaryIdInfos': [{'id': '2008-007939-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traumeel S ointment', 'description': 'Traumeel S ointment 2 g, 3 times daily topical during 14 days', 'interventionNames': ['Drug: Traumeel S ointment']}, {'type': 'EXPERIMENTAL', 'label': 'Traumeel S gel', 'description': 'Traumeel S gel 2 g, 3 times daily topical during 14 days', 'interventionNames': ['Drug: Traumeel S gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diclofenac gel', 'description': 'Diclofenac gel 2 g, 3 times daily topical during 14 days', 'interventionNames': ['Drug: Diclofenac gel']}], 'interventions': [{'name': 'Traumeel S ointment', 'type': 'DRUG', 'otherNames': ['Traumeel S ointment, Traumeel S gel, Diclofenac gel'], 'description': '2 g, 3 times daily topical during 14 days', 'armGroupLabels': ['Traumeel S ointment']}, {'name': 'Traumeel S gel', 'type': 'DRUG', 'description': '2 g, 3 times daily topical during 14 days', 'armGroupLabels': ['Traumeel S gel']}, {'name': 'Diclofenac gel', 'type': 'DRUG', 'description': '2 g, 3 times daily topical during 14 days', 'armGroupLabels': ['Diclofenac gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'MEDYR Medicina Deportiva y Rehabilitación', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Carlos Gonzalez de Vega, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Coordinating Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biologische Heilmittel Heel GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}