Topical Capsaicin for Cyclical Vomiting

Phase 2

Completed

• Conditions: Cyclical Vomiting
• Interventions: Drug: Capsaicin 0.1% Cream; Drug: Placebos

• Registration Number: NCT03223350
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Study Start: 2017-12-20
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Results First Submitted: 2021-11-07
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Results First Posted: 2021-12-15
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capsaicin	Capsaicin 0.1% Cream	0.1% capsaicin cream, one application
Placebo	Placebos	Topical cream with no active drug

Primary Outcome Measures

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

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States