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Domperidone for Gastroparesis in Solid Organ Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
David J. Lederer, M.D., Columbia University

October 31, 2007
November 1, 2007
June 2, 2015
July 10, 2015
July 10, 2015
March 2007
September 2010   (Final data collection date for primary outcome measure)
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.
Symptomatic Improvement [ Time Frame: 2 months ]
Complete list of historical versions of study NCT00552422 on Archive Site
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Domperidone for Gastroparesis in Solid Organ Transplantation
Domperidone for Gastroparesis Associated With Solid Organ Transplantation
The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.

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).

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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Gastroparesis
  • Gastroesophageal Reflux
Drug: domperidone
10mg orally four times per day
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.
Intervention: Drug: domperidone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2010
September 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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David J. Lederer, M.D., Columbia University
David J. Lederer, M.D.
Not Provided
Principal Investigator: David J Lederer, M.D. Columbia University
Columbia University
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP