Topical Capsaicin for Cyclical Vomiting

NCT03223350 — Phase 2, Completed, 30 participants, Henry Ford Health System

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Topical Capsaicin Cream for Treatment of Suspected Cyclical Vomiting Syndromes

Registry	NCT03223350
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	30 (Actual)
Sponsor	Henry Ford Health System (Other)
Conditions	Cyclical Vomiting
Interventions	Capsaicin 0.1% Cream, Placebos (Drug)
Dates	start 2017-12-20, primary completion 2019-08-05, completion 2019-08-05, first posted 2017-07-21, last updated 2021-12-15
Locations	1 site in United States

-Summary

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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Capsaicin	Experimental	Drug: Capsaicin 0.1% Cream	0.1% capsaicin cream, one application
Placebo	Placebo comparator	Drug: Placebos	Topical cream with no active drug

Capsaicin 0.1% Cream (Drug): Topical application
Placebos (Drug): placebo cream

+Outcome measures

Primary outcomes

Nausea Visual Analog Scale [30 minutes]: Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Posted results

Participant flow

Milestone	Capsaicin	Placebo
Started	17	13
Completed	17	13
Not completed	0	0

Outcome results

Nausea Visual Analog Scale (Primary), Mean, mm: Capsaicin 41 (28 to 54); Placebo 61 (41 to 81)

Adverse events

Time frame: 4 hours

Arm	Deaths	Serious adverse events	Other adverse events
Capsaicin	0/17 (0.0%)	0/17 (0.0%)	1/17 (5.9%)
Placebo	0/13 (0.0%)	0/13 (0.0%)	0/13 (0.0%)

Other adverse events by term

Term	Organ system	Capsaicin	Placebo
Skin irritation	Skin and subcutaneous tissue disorders	1/17	0/13

+Locations (1)

Facility	City	Country	Status
Henry Ford Hospital	Detroit, Michigan	United States

+Study documents

Study Protocol (PDF, 2017-04-05)
Statistical Analysis Plan (PDF, 2019-05-01)

+Investigators

Joseph Miller, MD, Principal investigator, Henry Ford Hospital

My Notes

Public

To Read Reading Read