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Topical Capsaicin for Cyclical Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03223350
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : December 22, 2017
Information provided by (Responsible Party):
Joseph Miller, MD, 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.

Condition or disease Intervention/treatment Phase
Cyclical Vomiting Drug: Capsaicin 0.075% Cream Drug: Placebos Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Identical appearing placebo cream used for control
Primary Purpose: Treatment
Official Title: Topical Capsaicin Cream for Treatment of Suspected Cyclical Vomiting Syndromes
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: Capsaicin
0.075% capsaicin cream, one application
Drug: Capsaicin 0.075% Cream
Topical application

Placebo Comparator: Placebo
Topical cream with no active drug
Drug: Placebos
placebo cream

Primary Outcome Measures :
  1. Nausea visual analog scale [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Vomiting [ Time Frame: 60 minutes ]
    categorical event

  2. Nausea visual analog scale [ Time Frame: 60 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • suspected cyclical vomiting syndrome
  • 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, use of prescription antiemetic in prior 24 hours, abdominal pain alone (without nausea or vomiting)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03223350

Contact: Joseph Miller, MD 3139165419

United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Joseph Miller, MD   
Sponsors and Collaborators
Henry Ford Health System
Principal Investigator: Joseph Miller, MD Henry Ford Hospital

Responsible Party: Joseph Miller, MD, Senior Staff, Henry Ford Health System Identifier: NCT03223350     History of Changes
Other Study ID Numbers: 10658
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs