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Domperidone for Gastroparesis in Solid Organ Transplantation

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ClinicalTrials.gov Identifier: NCT00552422
Recruitment Status : Terminated (Lack of perceived need for domperidone in this population)
First Posted : November 1, 2007
Results First Posted : July 10, 2015
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):
David J. Lederer, M.D., Columbia University

Study Description
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Brief Summary:
The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.

Condition or disease Intervention/treatment Phase
Gastroparesis Gastroesophageal Reflux Drug: domperidone Not Applicable

Detailed Description:

After heart or lung transplantation, the stomach tends to empty much slower than normal. This slow emptying is called "gastroparesis." Gastroparesis is uncomfortable and often leads to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and an inability to take oral medications, contributing to complications of transplantation. Treatments for gastroparesis include both medical and surgical therapies that work for some but not all patients.

Domperidone is a peripheral D2 antagonist that improves the emptying of the stomach in patients with gastroparesis. Domperidone is not FDA approved at this time. Some patients have developed lifethreatening abnormal heart rhythms after receiving domperidone intravenously. This problem has not been seen with domperidone given by mouth.

We propose to administer domperidone by mouth at standard doses to solid organ transplant patients who have gastroparesis that is not responsive to standard medical therapies or who experience adverse drug side effects. This study will not be blinded (open-label) and has a single treatment arm (no control or placebo group).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Domperidone for Gastroparesis Associated With Solid Organ Transplantation
Study Start Date : March 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Domperidone Arm
Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with significant renal impairment will be 20mg twice a day.
 Drug: domperidone
10mg orally four times per day


Outcome Measures
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Primary Outcome Measures :
  1. Symptomatic Improvement [ Time Frame: 2 months ]
    The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.


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

Inclusion Criteria:

  • gastroparesis or gastroesophageal reflux that is refractory to standard therapy.
  • signed informed consent

Exclusion Criteria:

  • serious cardiac arrhythmias
  • clinically significant bradycardia, sinus node dysfunction, or heart block.
  • prolonged QTc
  • clinically significant electrolyte disorders.
  • gastrointestinal hemorrhage or obstruction.
  • prolactinoma
  • pregnant or breast feeding female
  • known allergy to domperidone.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00552422


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
David J. Lederer, M.D.
Investigators
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Principal Investigator: David J Lederer, M.D. Columbia University
More Information
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Responsible Party: David J. Lederer, M.D., Herbert Irving Assistant Professor of Medicine and Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT00552422    
Other Study ID Numbers: AAAC3728
First Posted: November 1, 2007    Key Record Dates
Results First Posted: July 10, 2015
Last Update Posted: July 10, 2015
Last Verified: June 2015
Keywords provided by David J. Lederer, M.D., Columbia University:
gastroparesis
gastroesophageal reflux
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Gastroparesis
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Paralysis
Neurologic Manifestations
 Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action