Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 4:59 AM
Study NCT ID:
NCT01231750
Status:
TERMINATED
Last Update Posted:
2015-06-25
First Post:
2010-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Topical Capsaicin Cream for Stable Angina
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002211', 'term': 'Capsaicin'}, {'id': 'D016568', 'term': 'Drugs, Generic'}], 'ancestors': [{'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'faisal.khan@uc.edu', 'phone': '513-558-4272', 'title': 'Dr. Faisal Khan', 'organization': 'University of Cincinnati'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '18 months', 'description': 'Adverse events were assessed, but none observed.', 'eventGroups': [{'id': 'EG000', 'title': '0.1% Capsaicin Cream First, Then Placebo', 'description': 'Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo First, Then 0.1% Capsaicin', 'description': 'Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise\n\nPlacebo cream : cream, 4cm spread over 8cm x 15cm area of skin', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Symptom-limited Exercise Duration as an Indicator of Exercise Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.1% Capsaicin Cream First, Then Placebo', 'description': 'Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise'}, {'id': 'OG001', 'title': 'Placebo First, Then 0.1% Capsaicin', 'description': 'Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise\n\nPlacebo cream : cream, 4cm spread over 8cm x 15cm area of skin'}], 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Subjects walked on the treadmill as long as they could tolerate, symptom-limited.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected are no longer accessible.'}, {'type': 'PRIMARY', 'title': 'Time-to-onset of 1mm ST Segment Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.1% Capsaicin Cream First, Then Placebo', 'description': 'Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise'}, {'id': 'OG001', 'title': 'Placebo First, Then 0.1% Capsaicin', 'description': 'Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise\n\nPlacebo cream : cream, 4cm spread over 8cm x 15cm area of skin'}], 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected are no longer accessible.'}, {'type': 'PRIMARY', 'title': 'Time-to-onset of Angina or Angina Equivalent Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.1% Capsaicin Cream First, Then Placebo', 'description': 'Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise'}, {'id': 'OG001', 'title': 'Placebo First, Then 0.1% Capsaicin', 'description': 'Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise\n\nPlacebo cream : cream, 4cm spread over 8cm x 15cm area of skin'}], 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected are no longer accessible.'}, {'type': 'PRIMARY', 'title': 'Maximal ST Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.1% Capsaicin Cream First, Then Placebo', 'description': 'Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise'}, {'id': 'OG001', 'title': 'Placebo First, Then 0.1% Capsaicin', 'description': 'Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise\n\nPlacebo cream : cream, 4cm spread over 8cm x 15cm area of skin'}], 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected are no longer accessible.'}, {'type': 'PRIMARY', 'title': 'Maximal Estimated Workload (in METS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.1% Capsaicin Cream First, Then Placebo', 'description': 'Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise'}, {'id': 'OG001', 'title': 'Placebo First, Then 0.1% Capsaicin', 'description': 'Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise\n\nPlacebo cream : cream, 4cm spread over 8cm x 15cm area of skin'}], 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected are no longer accessible.'}, {'type': 'PRIMARY', 'title': 'Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.1% Capsaicin Cream First, Then Placebo', 'description': 'Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise'}, {'id': 'OG001', 'title': 'Placebo First, Then 0.1% Capsaicin', 'description': 'Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise\n\nPlacebo cream : cream, 4cm spread over 8cm x 15cm area of skin'}], 'timeFrame': 'Phase 2 was not done.', 'description': 'Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Severity of Angina Was Measured.', 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.1% Capsaicin Cream First, Then Placebo', 'description': 'Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise'}, {'id': 'FG001', 'title': 'Placebo First, Then 0.1% Capsaicin', 'description': 'Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise\n\nPlacebo cream : cream, 4cm spread over 8cm x 15cm area of skin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment goal not met.', 'preAssignmentDetails': 'Inclusion and exclusion criteria proved a large screening volume to yield few participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '0.1% Capsaicin Cream First, Then Placebo', 'description': 'Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise'}, {'id': 'BG001', 'title': 'Placebo First, Then 0.1% Capsaicin', 'description': 'Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise\n\nPlacebo cream : cream, 4cm spread over 8cm x 15cm area of skin'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Unable to identify study population to achieve number expected', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-23', 'studyFirstSubmitDate': '2010-10-28', 'resultsFirstSubmitDate': '2013-06-25', 'studyFirstSubmitQcDate': '2010-10-29', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-23', 'studyFirstPostDateStruct': {'date': '2010-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom-limited Exercise Duration as an Indicator of Exercise Capacity', 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Subjects walked on the treadmill as long as they could tolerate, symptom-limited.'}, {'measure': 'Time-to-onset of 1mm ST Segment Depression', 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.'}, {'measure': 'Time-to-onset of Angina or Angina Equivalent Symptoms', 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.'}, {'measure': 'Maximal ST Depression', 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.'}, {'measure': 'Maximal Estimated Workload (in METS)', 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).'}, {'measure': 'Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)', 'timeFrame': 'Phase 2 was not done.', 'description': 'Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.'}, {'measure': 'Severity of Angina Was Measured.', 'timeFrame': 'Application was 45 minutes prior to exercise', 'description': 'Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stable Angina']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis that application of topical capsaicin in patients with stable angina will result in improved exercise tolerance and reduced cardiac ischemia.', 'detailedDescription': 'Patients with stable angina on medical therapy who are capable of exercising on a treadmill and have an interpretable ECG for ischemia will be enrolled in the study, which entails performing two treadmill tests approximately one week apart following topical treatment with placebo cream or topical capsaicin (randomized in crossover fashion). Patients will be monitored for exercise tolerance, anginal symptoms, ECG for ischemia/arrhythmia, and hemodynamic responses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> or = 3 month history of chronic, stable, angina triggered by physical effort or mental/emotional stress\n* documented stress-induced ST depression, reversible perfusion imaging, or wall motion abnormality or CAD \\>50%\n* Canadian Cardiovascular (CV) Class I-III\n* Receiving medical therapy for \\> or = 2 months\n* Ability to perform Bruce Protocol treadmill test\n* non-pregnant female\n\nExclusion Criteria:\n\n* unstable angina\n* revasc within 2 months\n* Myocardial infarction (MI) within 2 months\n* congestive heart failure (CHF) hospitalization within 2 months\n* New York Heart Association (NYHA) class III or IV\n* left ventricular ejection fraction (LVEF) \\< 25%\n* abnormal ECG; Acute changes on ECG\n* Currently receiving treatment with investigational drugs/devices\n* Uncontrolled hypertension\n* contraindication to exercise stress testing\n* allergy to red peppers or capsaicin\n* skin deformity, scar, or rash at application site\n* abdominal surgery within 3 months'}, 'identificationModule': {'nctId': 'NCT01231750', 'acronym': 'TOPCAP', 'briefTitle': 'Efficacy of Topical Capsaicin Cream for Stable Angina', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)', 'orgStudyIdInfo': {'id': 'UC 060559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0.1% Capsaicin Cream', 'description': '0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise', 'interventionNames': ['Drug: Capsaicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Cream', 'description': 'Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise', 'interventionNames': ['Other: Placebo cream']}], 'interventions': [{'name': 'Capsaicin', 'type': 'DRUG', 'otherNames': ['capsaicin cream 0.1%, generic'], 'description': '0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise', 'armGroupLabels': ['0.1% Capsaicin Cream']}, {'name': 'Placebo cream', 'type': 'OTHER', 'otherNames': ['cream, placebo'], 'description': 'cream, 4cm spread over 8cm x 15cm area of skin', 'armGroupLabels': ['Placebo Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Physicians, Inc', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Faisal M Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neal Weintraub', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Neal Weintraub', 'investigatorAffiliation': 'University of Cincinnati'}}}}