Topical Capsaicin for Cyclical Vomiting

• Sponsor: Henry Ford Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT03223350
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.5
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the relieve of nausea and vomiting.

Condition or Disease	Intervention/Treatment	Phase
Cyclical Vomiting	Drug: Capsaicin 0.1% Cream; Drug: Placebos	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Identical appearing placebo cream used for control
• Primary Purpose: Treatment
• Official Title: Topical Capsaicin Cream for Treatment of Suspected Cyclical Vomiting Syndromes
• Actual Study Start Date: Dec 20, 2017
• Actual Primary Completion Date: Aug 5, 2019
• Actual Study Completion Date: Aug 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Capsaicin 0.1% capsaicin cream, one application	Drug: Capsaicin 0.1% Cream; Topical application
Placebo Comparator: Placebo Topical cream with no active drug	Drug: Placebos; placebo cream

Outcome Measures

Primary Outcome Measures

1. Nausea Visual Analog Scale [30 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• suspected cyclical vomiting syndrome / cannabinoid hyperemesis

• active severe nausea or vomiting in the emergency department

Exclusion Criteria:

• pregnant women, children < 18 years, no prior history of similar symptoms, suspected surgical or infectious cause of symptoms, suspected hepatitis or pancreatitis, allergy to capsaicin or hot peppers, chronic use of prescription antiemetic in prior 24 hours, abdominal pain alone (without nausea or vomiting)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Hospital	Detroit	Michigan	United States	48202

Sponsors and Collaborators

• Henry Ford Health System

Investigators

• Principal Investigator: Joseph Miller, MD, Henry Ford Hospital

Study Documents (Full-Text)

• Study Protocol - Apr 5, 2017
• Statistical Analysis Plan - May 1, 2019

More Information

Publications

None provided.

• Responsible Party: Joseph Miller, MD, Senior Staff, Henry Ford Health System
• ClinicalTrials.gov Identifier: NCT03223350
• Other Study ID Numbers: 10658
• First Posted: Jul 21, 2017
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Vomiting; Capsaicin

Study Results

Participant Flow

Arm/Group Title	Capsaicin	Placebo
Arm/Group Description	0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application	Topical cream with no active drug Placebos: placebo cream
Period Title: Overall Study
STARTED	17	13
COMPLETED	17	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Capsaicin	Placebo	Total
Arm/Group Description	0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application	Topical cream with no active drug Placebos: placebo cream	Total of all reporting groups
Overall Participants	17	13	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.4 (15.3)	27.5 (5.2)	32.0 (12.5)
Sex: Female, Male (Count of Participants)
Female	10 58.8%	5 38.5%	15 50%
Male	7 41.2%	8 61.5%	15 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	15 88.2%	12 92.3%	27 90%
White	1 5.9%	1 7.7%	2 6.7%
More than one race	1 5.9%	0 0%	1 3.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	17 100%	13 100%	30 100%
Nausea on visual analog scale (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	60 (29)	85 (20)	71 (28)

Outcome Measures

1. Primary Outcome

Title	Nausea Visual Analog Scale
Description	Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

Patients identified with cannabinoid hyperemesis

Arm/Group Title	Capsaicin	Placebo
Arm/Group Description	0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application	Topical cream with no active drug Placebos: placebo cream
Measure Participants	17	13
Mean (95% Confidence Interval) [mm]	41	61

Adverse Events

Time Frame	4 hours
Arm/Group Title	Capsaicin		Placebo
Arm/Group Description	0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application		Topical cream with no active drug Placebos: placebo cream
All Cause Mortality
	Capsaicin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/13 (0%)
Serious Adverse Events
	Capsaicin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Capsaicin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/17 (5.9%)		0/13 (0%)
Skin and subcutaneous tissue disorders
Skin irritation	1/17 (5.9%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.