Trial Outcomes & Findings for Efficacy of Topical Capsaicin Cream for Stable Angina (NCT NCT01231750)

Results Overview

Subjects walked on the treadmill as long as they could tolerate, symptom-limited.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

7 participants

Primary outcome timeframe

Application was 45 minutes prior to exercise

Results posted on

2015-06-25

Participant Flow

Recruitment goal not met.

Inclusion and exclusion criteria proved a large screening volume to yield few participants.

Participant milestones

Participant milestones
Measure	0.1% Capsaicin Cream First, Then Placebo Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise	Placebo First, Then 0.1% Capsaicin Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin
Overall Study STARTED	3	4
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Topical Capsaicin Cream for Stable Angina

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.1% Capsaicin Cream First, Then Placebo n=3 Participants Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise	Placebo First, Then 0.1% Capsaicin n=4 Participants Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Application was 45 minutes prior to exercise

Population: Data collected are no longer accessible.

Subjects walked on the treadmill as long as they could tolerate, symptom-limited.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Application was 45 minutes prior to exercise

Population: Data collected are no longer accessible.

Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Application was 45 minutes prior to exercise

Population: Data collected are no longer accessible.

Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Application was 45 minutes prior to exercise

Population: Data collected are no longer accessible.

Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Application was 45 minutes prior to exercise

Population: Data collected are no longer accessible.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

0.1% Capsaicin Cream First, Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo First, Then 0.1% Capsaicin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Faisal Khan

University of Cincinnati

Phone: 513-558-4272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place