Domperidone for Refractory Gastrointestinal Disorders

August 17, 2016 updated by: George Arnold, MD, Arnold, George, M.D.

An Investigational New Drug Program for the Use of Domperidone in the Treatment of Refractory Gastroesophageal Reflux Disease and Other Gastrointestinal Motility Disorders

The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Domperidone is a dopamine-2 receptor antagonist. It acts as a prokinetic agent through its effects on the chemoreceptor trigger zone and the motor function of the stomach and small intestines. It does not cause any adverse neurological symptoms and has an excellent safety profile for long-term oral administration in recommended doses.

In the United States, domperidone is not approved by the Food and Drug Administration (FDA) and cannot be obtained by routine prescriptions or covered by health care insurance plans. It is also illegal to write a prescription for the subject to obtain the drug outside the U.S. Domperidone can be administered legally by obtaining a FDA Investigational New Drug (IND) application with Institutional Review Board (IRB) approval.

This study will follow FDA and IRB regulations and provide domperidone to subjects with gastrointestinal disorders who have failed from standard therapy.

Study Type

Interventional

Enrollment (Anticipated)

75

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Division of Gastroenterology, Hepatology and Nutrition, UPMC Presbyterian Digesive Disorders Center, 3rd Floor, 200 Lothrop Street
        • Contact:
        • Principal Investigator:
          • George L. Arnold, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female
  • Age 18 or older
  • Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
  • Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.

  • Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:

    • increased prolactin levels
    • extrapyramidal side effects
    • breast changes
    • cardiac arrhythmias including QT prolongation
    • there is a potential for increased risk of adverse events with the drugs listed in the addendum

Exclusion Criteria:

  • History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
  • History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
  • Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
  • Presence of a prolactinoma (prolactin-releasing pituitary tumor).
  • Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo- obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
  • Pregnant or breast feeding female.
  • Known allergy to domperidone or any components of the domperidone formulation.
  • Significantly significant electrolyte disorders.
  • Gastrointestinal hemorrhage or obstruction.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Domperidone
All eligible subjects will receive domperidone in an open label, single group assignment.
Drug: Domperidone
10 mg of oral domperidone will be administered 4 times daily. This dose may be increased to 20 mg 4 times daily or 30 mg 4 times daily, depending on how the subject responds to the drug.
Other Names:
  • Domperidone maleate, Motilium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of symptoms for patients with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.
Time Frame: Domperidone will be prescrided as long as patients benefit from taking it.
Domperidone will be prescrided as long as patients benefit from taking it.

Collaborators and Investigators

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

Sponsor

Arnold, George, M.D.

Investigators

  • Principal Investigator: George L. Arnold, MD, George L. Arnold, MD, FACP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2008

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

October 21, 2008

First Submitted That Met QC Criteria

October 21, 2008

First Posted (Estimate)

October 22, 2008

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLA102024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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