Efficacy of Topical Capsaicin Cream for Stable Angina

Stable Angina Clinical Trial

— TOPCAP  

Official title:

A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01231750
• Other study ID #: UC 060559
• Status: Terminated
• Phase: Phase 3
• First received: October 28, 2010
• Last updated: June 23, 2015
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: June 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• > or = 3 month history of chronic, stable, angina triggered by physical effort or mental/emotional stress

• documented stress-induced ST depression, reversible perfusion imaging, or wall motion abnormality or CAD >50%

• Canadian Cardiovascular (CV) Class I-III

• Receiving medical therapy for > or = 2 months

• Ability to perform Bruce Protocol treadmill test

• non-pregnant female

Exclusion Criteria:

• unstable angina

• revasc within 2 months

• Myocardial infarction (MI) within 2 months

• congestive heart failure (CHF) hospitalization within 2 months

• New York Heart Association (NYHA) class III or IV

• left ventricular ejection fraction (LVEF) < 25%

• abnormal ECG; Acute changes on ECG

• Currently receiving treatment with investigational drugs/devices

• Uncontrolled hypertension

• contraindication to exercise stress testing

• allergy to red peppers or capsaicin

• skin deformity, scar, or rash at application site

• abdominal surgery within 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Stable Angina

Intervention

Drug:
• Capsaicin
0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise

Other:
• Placebo cream
cream, 4cm spread over 8cm x 15cm area of skin

Locations

Country	Name	City	State
United States	University of Cincinnati Physicians, Inc	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Neal Weintraub	University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom-limited Exercise Duration as an Indicator of Exercise Capacity	Subjects walked on the treadmill as long as they could tolerate, symptom-limited.	Application was 45 minutes prior to exercise	No
Primary	Time-to-onset of 1mm ST Segment Depression	Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.	Application was 45 minutes prior to exercise	No
Primary	Time-to-onset of Angina or Angina Equivalent Symptoms	Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.	Application was 45 minutes prior to exercise	No
Primary	Maximal ST Depression	Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.	Application was 45 minutes prior to exercise	No
Primary	Maximal Estimated Workload (in METS)	Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).	Application was 45 minutes prior to exercise	No
Primary	Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)	Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.	Phase 2 was not done.	No
Primary	Severity of Angina Was Measured.	Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.	Application was 45 minutes prior to exercise	No