Efficacy of Topical Capsaicin Cream for Stable Angina (TOPCAP)
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|ClinicalTrials.gov Identifier: NCT01231750|
Recruitment Status : Terminated (Unable to identify study population to achieve number expected)
First Posted : November 1, 2010
Results First Posted : June 25, 2015
Last Update Posted : June 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stable Angina||Drug: Capsaicin Other: Placebo cream||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Active Comparator: 0.1% Capsaicin Cream
0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise
0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
Other Name: capsaicin cream 0.1%, generic
Placebo Comparator: Placebo Cream
Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise
Other: Placebo cream
cream, 4cm spread over 8cm x 15cm area of skin
Other Name: cream, placebo
- Symptom-limited Exercise Duration as an Indicator of Exercise Capacity [ Time Frame: Application was 45 minutes prior to exercise ]Subjects walked on the treadmill as long as they could tolerate, symptom-limited.
- Time-to-onset of 1mm ST Segment Depression [ Time Frame: Application was 45 minutes prior to exercise ]Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.
- Time-to-onset of Angina or Angina Equivalent Symptoms [ Time Frame: Application was 45 minutes prior to exercise ]Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.
- Maximal ST Depression [ Time Frame: Application was 45 minutes prior to exercise ]Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.
- Maximal Estimated Workload (in METS) [ Time Frame: Application was 45 minutes prior to exercise ]Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).
- Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2) [ Time Frame: Phase 2 was not done. ]Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.
- Severity of Angina Was Measured. [ Time Frame: Application was 45 minutes prior to exercise ]Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231750
|United States, Ohio|
|University of Cincinnati Physicians, Inc|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Faisal M Khan, MD||University of Cincinnati|