Domperidone for Refractory Gastrointestinal Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Arnold, George, M.D.
Sponsor:
Information provided by (Responsible Party):
George Arnold, MD, Arnold, George, M.D.
ClinicalTrials.gov Identifier:
NCT00777439
First received: October 21, 2008
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Gastroparesis
Drug: Domperidone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigational New Drug Program for the Use of Domperidone in the Treatment of Refractory Gastroesophageal Reflux Disease and Other Gastrointestinal Motility Disorders

Resource links provided by NLM:


Further study details as provided by Arnold, George, M.D.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2008
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Domperidone maleate, Motilium

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777439

Contacts
Contact: Mary R. Beaves, BSN 412-623-1309 beavesmr@upmc.edu
Contact: George L. Arnold, MD 412-621-2334 arnoldgl@upmc.edu

Locations
United States, Pennsylvania
Associates in Gastroenterology Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Mary R. Beaves, BSN    412-623-1309    beavesmr@upmc.edu   
Principal Investigator: George L. Arnold, MD         
Sponsors and Collaborators
Arnold, George, M.D.
Investigators
Principal Investigator: George L. Arnold, MD George L. Arnold, MD, FACP
  More Information

Publications:
Responsible Party: George Arnold, MD, Principal Investigator, Arnold, George, M.D.
ClinicalTrials.gov Identifier: NCT00777439     History of Changes
Other Study ID Numbers: GLA102024
Study First Received: October 21, 2008
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Arnold, George, M.D.:
Dopamine
Domperidone
Gastroparesis
Gastrointestinal Diseases
Neurologic Manifestations
Stomach Diseases
Digestive System Diseases
Esophagitis
Esophageal Disorders
Paralysis

Additional relevant MeSH terms:
Stomach Diseases
Gastroesophageal Reflux
Gastroparesis
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014