Domperidone for Gastroparesis in Solid Organ Transplantation - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Domperidone for Gastroparesis Associated With Solid Organ Transplantation

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Domperidone Domperidone maleate

U.S. FDA Resources

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
Experimental: 1 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

Locations

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

David J Lederer, M.D.

Columbia University

More Information

No publications provided

Responsible Party:	David Lederer, Columbia University
ClinicalTrials.gov Identifier:	NCT00552422 History of Changes
Other Study ID Numbers:	AAAC3728
Study First Received:	October 31, 2007
Last Updated:	March 15, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Columbia University:

gastroparesis
gastroesophageal reflux

Additional relevant MeSH terms:

Gastroesophageal Reflux
Gastroparesis
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach 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 February 09, 2012