Efficacy of Topical Capsaicin Cream for Stable Angina (TOPCAP)
This study has been terminated.
(Unable to identify study population to achieve number expected)
University of Cincinnati
Information provided by (Responsible Party):
Neal Weintraub, University of Cincinnati
First received: October 28, 2010
Last updated: February 25, 2013
Last verified: February 2013
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)|
Resource links provided by NLM:
Drug Information available for: Edetic acid Sodium calcium edetate Pentetic acid Edetate sodium Capsaicin Calcium DTPA Edetate calcium disodium Pentetate Calcium Trisodium 5-Chloro-2-methyl-4-isothiazolin-3-oneU.S. FDA Resources
Further study details as provided by University of Cincinnati:
Primary Outcome Measures:
- Symptom-limited exercise duration as an indicator of exercise capacity [ Time Frame: Application 45 minutes prior to exercise ] [ Designated as safety issue: Yes ]Subjects will walk on the treadmill as long as they can tolerate, symptom-limited.
- Time-to-onset of 1mm ST segment depression [ Time Frame: Application 45 minutes prior to exercise ] [ Designated as safety issue: Yes ]Continuous ECG will be recorded during exercise. Data will be interpreted by a board-certified cardiologist.
- Time-to-onset, and severity, of angina or angina equivalent symptoms [ Time Frame: Application 45 minutes prior to exercise ] [ Designated as safety issue: Yes ]Onset of angina or angina-equivalent symptoms, severity (numerical score 1 to 10, where 10 is the worst intensity and 1 is the least), as well as descriptive quality, will be assessed from beginning of exercise.
- Maximal ST depression [ Time Frame: Applicaiton 45 minutes prior to exercise ] [ Designated as safety issue: Yes ]Exercise ECG data will be interpreted by a board certified cardiologist to assess maximal ST depression.
- Peak rate-pressure product and maximal estimated workload (in METS) during exercise tolerance test (ETT) [ Time Frame: Application 45 minutes prior to exercise ] [ Designated as safety issue: Yes ]Peak rate-pressure and maximal estimated workload will be analyzed.
- Magnitude of reversible perfusion defect in SPECT perfusion study with wall motion assessment (phase 2) [ Time Frame: Application 45 minutes prior to exercise ] [ Designated as safety issue: No ]Images will be processed and analyzed using standard laboratory methodology, including computer generated calculations of Summed Stress Score (SSS) and Summed Difference Score (SDS). Blind readers will complete the Visual Interpretation Report and Quantitative Image Report.
|Study Start Date:||October 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: 0.1% Capsaicin Cream||
0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
Placebo Comparator: Placebo
Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Other: Placebo cream
cream, 4cm spread over 8cm x 15cm area of skin
Other Name: Composed of water, petrolatum, cetyl alcohol, stearyl alcohol, miral oil, polysorbate 80, disodium EDTA, BHT, Methylchloroisothiazolinone
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231750
|United States, Ohio|
|University of Cincinnati Physicians, Inc|
|Cincinnati, Ohio, United States, 45219|
Sponsors and Collaborators
University of Cincinnati
|Principal Investigator:||Faisal M Khan, MD||University of Cincinnati|