Efficacy of Topical Capsaicin Cream for Stable Angina

NCT ID: NCT01231750

Last Updated: 2015-06-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-03-31

Brief 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.

Detailed 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.

Conditions

Stable Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.1% Capsaicin Cream

0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise

Group Type: ACTIVE_COMPARATOR

Capsaicin

Intervention Type: DRUG

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

Placebo Cream

Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise

Group Type: PLACEBO_COMPARATOR

Placebo cream

Intervention Type: OTHER

cream, 4cm spread over 8cm x 15cm area of skin

Interventions

Capsaicin

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

Intervention Type: DRUG

Placebo cream

cream, 4cm spread over 8cm x 15cm area of skin

Intervention Type: OTHER

Other Intervention Names

capsaicin cream 0.1%, generic; cream, placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: collaborator

Neal Weintraub

OTHER

Sponsor Role: lead

Responsible Party

Neal Weintraub

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Faisal M Khan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati Physicians, Inc

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

UC 060559

Identifier Type: -

Identifier Source: org_study_id