Trial Outcomes & Findings for Topical Capsaicin for Cyclical Vomiting (NCT NCT03223350)

NCT ID: NCT03223350

Last Updated: 2021-12-15

Results Overview

Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2021-12-15

Participant Flow

Participant milestones

Measure	Capsaicin 0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application	Placebo Topical cream with no active drug Placebos: placebo cream
Overall Study STARTED	17	13
Overall Study COMPLETED	17	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Capsaicin for Cyclical Vomiting

Baseline characteristics by cohort

Measure	Capsaicin n=17 Participants 0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application	Placebo n=13 Participants Topical cream with no active drug Placebos: placebo cream	Total n=30 Participants Total of all reporting groups
Age, Continuous	35.4 years STANDARD_DEVIATION 15.3 • n=5 Participants	27.5 years STANDARD_DEVIATION 5.2 • n=7 Participants	32.0 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	13 participants n=7 Participants	30 participants n=5 Participants
Nausea on visual analog scale	60 mm STANDARD_DEVIATION 29 • n=5 Participants	85 mm STANDARD_DEVIATION 20 • n=7 Participants	71 mm STANDARD_DEVIATION 28 • n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Population: Patients identified with cannabinoid hyperemesis

Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea

Outcome measures

Measure	Capsaicin n=17 Participants 0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application	Placebo n=13 Participants Topical cream with no active drug Placebos: placebo cream
Nausea Visual Analog Scale	41 mm Interval 28.0 to 54.0	61 mm Interval 41.0 to 81.0

Adverse Events

Capsaicin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Capsaicin n=17 participants at risk 0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application	Placebo n=13 participants at risk Topical cream with no active drug Placebos: placebo cream
Skin and subcutaneous tissue disorders Skin irritation	5.9% 1/17 • 4 hours	0.00% 0/13 • 4 hours

Additional Information

Dr. Joseph Miller, associate research director

Henry Ford Hospital

Phone: 313-916-5419

Email: jmiller6@hfhs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place