Efficacy of Topical Capsaicin Cream for Stable Angina

NCT01231750 | Terminated Phase 3 Results DMC

• 1 other identifier: UC 060559
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• Maximal Estimated Workload (in METS)

  Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).

  Application was 45 minutes prior to exercise

• 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.

• 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

Study Arms (2)

0.1% Capsaicin Cream

ACTIVE COMPARATOR

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

Drug: Capsaicin

Placebo Cream

PLACEBO COMPARATOR

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

Other: Placebo cream

Interventions

Capsaicin DRUG

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

Also known as: capsaicin cream 0.1%, generic

0.1% Capsaicin Cream

Placebo cream OTHER

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

Also known as: cream, placebo

Placebo Cream

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neal Weintraub: lead
• University of Cincinnati: collaborator

Study Sites (1)

University of Cincinnati Physicians, Inc

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Angina, Stable

Interventions

Capsaicin; Drugs, Generic

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Faisal Khan
• Organization: University of Cincinnati

faisal.khan@uc.edu

513-558-4272

Study Officials

• Faisal M Khan, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 1, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 25, 2015
• Results First Posted: June 25, 2015

Record last verified: 2015-06

Locations

US (1)