Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying

May 15, 2017 updated by: Jamie S. Barkin, M.D., Mt. Sinai Medical Center, Miami

Clinical Applications of Domperidone in Patients With Refractory Gastroesophageal Reflux Disease or Delayed Gastric Solid-Phase Emptying

The purpose of the study is to treat patients with on-going slow stomach emptying(gastroesophageal reflux disease), who have failed to respond to standard therapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a study on the effectiveness of domperidone, which increases movement through the digestive system for relief of symptoms, in patients who have delayed gastric solid-phase emptying

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Division of Gastroenterology, Mt. Sinai Medical Center
      • Miami Beach, Florida, United States, 33140
        • Mt. Sinai Medical Center, Division of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persistent esophagitis
  • Heartburn
  • Nausea
  • Vomiting
  • Severe dyspepsia
  • Severe chronic constipation

Exclusion Criteria:

  • History of, or current arrhythmias including ventricular tachycardia, - Ventricular fibrillation and Torsade des Pointes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Domperidone
Domperidone will be given at 10 mg before each meal and at bedtime. At completion of the study, patients will receive standard medical therapy
Other: Domperidone
Domperidone dosage may be increased depending on how well the patient responds. However before increasing the dosage, patients will have follow-up EKG to evaluate any possible side effects including irregular heartbeats.
Other Names:
  • Motilium
  • Motillium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying
Time Frame: 5 years
GERD or Delayed Gastric Emptying
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mt. Sinai Medical Center, Miami

Investigators

  • Principal Investigator: Jamie S. Barkin, M.D., Mt. Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

February 19, 2015

Study Completion (Actual)

February 19, 2015

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-39-H-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Digestive System Disease

Clinical Trials on Domperidone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe