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Topical Capsaicin for Cyclical Vomiting

Primary Purpose

Cyclical Vomiting

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Capsaicin 0.1% Cream

Placebos

About this trial

This is an interventional treatment trial for Cyclical Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Capsaicin

Placebo

Arm Description

0.1% capsaicin cream, one application

Topical cream with no active drug

Outcomes

Primary Outcome Measures

Nausea Visual Analog Scale

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03223350

First Posted

July 18, 2017

Last Updated

December 14, 2021

Sponsor

Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT03223350

Brief Title

Topical Capsaicin for Cyclical Vomiting

Official Title

Topical Capsaicin Cream for Treatment of Suspected Cyclical Vomiting Syndromes

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

December 20, 2017 (Actual)

Primary Completion Date

August 5, 2019 (Actual)

Study Completion Date

August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cyclical Vomiting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Identical appearing placebo cream used for control

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Capsaicin

Arm Type

Experimental

Arm Description

0.1% capsaicin cream, one application

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Topical cream with no active drug

Intervention Type

Drug

Intervention Name(s)

Capsaicin 0.1% Cream

Intervention Description

Topical application

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

placebo cream

Primary Outcome Measure Information:

Title

Nausea Visual Analog Scale

Description

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

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Miller, MD

Organizational Affiliation

Henry Ford Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Topical Capsaicin for Cyclical Vomiting

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