Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying

NCT ID: NCT01844622

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2015-02-19

Brief Summary

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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

Detailed Description

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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

Conditions

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Digestive System Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Domperidone

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Motilium Motillium

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mt. Sinai Medical Center, Miami

OTHER

Sponsor Role lead

Responsible Party

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Jamie S. Barkin, M.D.

Professor of Medicine, U of Miami and Chief, Div of GI, Mt. Sinai Med. Ctr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamie S. Barkin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mt. Sinai Medical Center

Locations

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Division of Gastroenterology, Mt. Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Mt. Sinai Medical Center, Division of Gastroenterology

Miami Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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07-39-H-08

Identifier Type: -

Identifier Source: org_study_id

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