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Efficacy of Topical Capsaicin Cream for Stable Angina (TOPCAP)

This study has been terminated.
(Unable to identify study population to achieve number expected)
Sponsor:
Information provided by (Responsible Party):
Neal Weintraub, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01231750
First received: October 28, 2010
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Stable Angina
Drug: Capsaicin
Other: Placebo cream
Phase 3

Study Type: Interventional
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:


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.


Enrollment: 9
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.1% Capsaicin Cream Drug: Capsaicin
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231750

Locations
United States, Ohio
University of Cincinnati Physicians, Inc
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Faisal M Khan, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Neal Weintraub, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01231750     History of Changes
Other Study ID Numbers: UC 060559
Study First Received: October 28, 2010
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
5-chloro-2-methyl-4-isothiazolin-3-one
Capsaicin
Anti-Infective Agents
Antipruritics
Dermatologic Agents
Disinfectants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014