Topical Capsaicin for Cyclical Vomiting

Topical Capsaicin Cream for Treatment of Suspected Cyclical Vomiting Syndromes

Sponsors

Lead Sponsor: Henry Ford Health System

Source Henry Ford Health System
Brief Summary

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

Overall Status Completed
Start Date December 20, 2017
Completion Date August 5, 2019
Primary Completion Date August 5, 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Nausea visual analog scale 30 minutes
Secondary Outcome
Measure Time Frame
Vomiting 60 minutes
Nausea visual analog scale 60 minutes
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Capsaicin 0.1% Cream

Description: Topical application

Arm Group Label: Capsaicin

Intervention Type: Drug

Intervention Name: Placebos

Description: placebo cream

Arm Group Label: Placebo

Eligibility

Criteria:

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Joseph Miller, MD Principal Investigator Henry Ford Hospital
Location
Facility: Henry Ford Hospital
Location Countries

United States

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Henry Ford Health System

Investigator Full Name: Joseph Miller, MD

Investigator Title: Senior Staff

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Capsaicin

Type: Experimental

Description: 0.1% capsaicin cream, one application

Label: Placebo

Type: Placebo Comparator

Description: Topical cream with no active drug

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Identical appearing placebo cream used for control

Source: ClinicalTrials.gov