Efficacy of Topical Capsaicin Cream for Stable Angina (TOPCAP)
|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.
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|