Stable AnginaPhase 3TOPCAPNCT01231750
Efficacy of Topical Capsaicin Cream for Stable Angina
A Phase 3 study testing Capsaicin in people with Stable Angina, run by Neal Weintraub at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stable Angina
- What is being tested?
- Capsaicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Mar 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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%
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Physicians, Inc
Cincinnati, Ohio, 45219
About this study
Official title: A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)
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.
Read the 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
- Being tested
- Capsaicin, Placebo cream
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
Also called capsaicin cream 0.1%, generic
0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
Placebo creamOther
Also called cream, placebo
cream, 4cm spread over 8cm x 15cm area of skin
| Study group | Role | What they receive |
|---|---|---|
| 0.1% Capsaicin Cream | Active comparator | 0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise Receives: Drug: Capsaicin |
| Placebo Cream | Placebo comparator | Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise Receives: Other: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom-limited Exercise Duration as an Indicator of Exercise Capacity
Subjects walked on the treadmill as long as they could tolerate, symptom-limited.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Application was 45 minutes prior to exercise
Maximal Estimated Workload (in METS)
Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).
Measured: 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.
Measured: 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.
Measured: Application was 45 minutes prior to exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Unable to identify study population to achieve number expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neal Weintraub
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor-investigator, Neal Weintraub, University of Cincinnati
- Investigators
- Faisal M Khan, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231750
- Sponsor's protocol ID
- UC 060559
- Acronym
- TOPCAP
- Status last verified
- Jun 2015
- First submitted
- 28 Oct 2010
- Last updated
- 25 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)
- ClinicalTrials.gov ID
- NCT01231750
- Acronym / sponsor ID
- TOPCAP / UC 060559
- Conditions
- Stable Angina
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to identify study population to achieve number expected
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Neal WeintraubUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Posted 25 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.1% Capsaicin Cream | Active comparator | Drug: Capsaicin0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise |
| Placebo Cream | Placebo comparator | Other: Placebo creamInactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsaicinAlso: capsaicin cream 0.1%, generic0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise | Drug | 0.1% Capsaicin Cream |
| Placebo creamAlso: cream, placebocream, 4cm spread over 8cm x 15cm area of skin | Other | Placebo Cream |
Primary outcome
Symptom-limited Exercise Duration as an Indicator of Exercise Capacity
Time frame: Application was 45 minutes prior to exercise
Subjects walked on the treadmill as long as they could tolerate, symptom-limited.
Time-to-onset of 1mm ST Segment Depression
Time frame: Application was 45 minutes prior to exercise
Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.
Time-to-onset of Angina or Angina Equivalent Symptoms
Time frame: Application was 45 minutes prior to exercise
Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.
Maximal ST Depression
Time frame: Application was 45 minutes prior to exercise
Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.
Maximal Estimated Workload (in METS)
Time frame: Application was 45 minutes prior to exercise
Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).
Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)
Time frame: Phase 2 was not done.
Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.
Severity of Angina Was Measured.
Time frame: Application was 45 minutes prior to exercise
Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faisal M Khan, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capsaicin in people with Stable Angina, run by Neal Weintraub at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom-limited Exercise Duration as an Indicator of Exercise Capacity (time frame: Application was 45 minutes prior to exercise). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.