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Domperidone for Gastroparesis in Solid Organ Transplantation

This study is currently recruiting participants.
Verified by Columbia University, May 2008

Sponsored by: Columbia University
Information provided by: Columbia University
ClinicalTrials.gov Identifier: NCT00552422
  Purpose

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


Condition Intervention
Gastroparesis
Gastroesophageal Reflux
Drug: domperidone

MedlinePlus related topics:   GERD   

ChemIDplus related topics:   Domperidone    Domperidone maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Domperidone for Gastroparesis Associated With Solid Organ Transplantation

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Symptomatic improvement [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   25
Study Start Date:   March 2007
Estimated Study Completion Date:   January 2013
Estimated Primary Completion Date:   December 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Domperidone
Drug: domperidone
10mg orally four times per day

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).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552422

Contacts
Contact: David J Lederer, M.D.     (212) 305-7771    

Locations
United States, New York
Columbia University Medical Center     Recruiting
      New York, New York, United States, 10032
      Contact     212-305-7771        
      Principal Investigator: David J Lederer, M.D., M.S.            
      Sub-Investigator: Thresiamma Lukose, Pharm.D.            
      Sub-Investigator: Selim M Arcasoy, M.D.            
      Sub-Investigator: Jessie Wilt, M.D.            
      Sub-Investigator: Steven M Kawut, M.D., M.S.            

Sponsors and Collaborators
Columbia University

Investigators
Principal Investigator:     David J Lederer, M.D.     Columbia University    
  More Information


Responsible Party:   Columbia University ( David Lederer )
Study ID Numbers:   AAAC3728
First Received:   October 31, 2007
Last Updated:   May 22, 2008
ClinicalTrials.gov Identifier:   NCT00552422
Health Authority:   United States: Food and Drug Administration

Keywords provided by Columbia University:
gastroparesis  
gastroesophageal reflux  

Study placed in the following topic categories:
Esophageal disorder
Gastrointestinal Diseases
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Paralysis
Signs and Symptoms
Dopamine
Digestive System Diseases
Stomach Diseases
Domperidone
Neurologic Manifestations
Esophageal Diseases
Gastroparesis

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Dopamine Agents
Dopamine Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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