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Topical Capsaicin for Cyclical Vomiting

NCT ID: NCT03223350

Last Updated: 2021-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2019-08-05

Brief Summary

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

Detailed Description

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Conditions

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Cyclical Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Identical appearing placebo cream used for control

Study Groups

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Capsaicin

0.1% capsaicin cream, one application

Group Type EXPERIMENTAL

Capsaicin 0.1% Cream

Intervention Type DRUG

Topical application

Placebo

Topical cream with no active drug

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

placebo cream

Interventions

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Capsaicin 0.1% Cream

Topical application

Intervention Type DRUG

Placebos

placebo cream

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Joseph Miller, MD

Senior Staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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10658

Identifier Type: -

Identifier Source: org_study_id