Domperidone for Gastroparesis in Solid Organ Transplantation
The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.
|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|
- Symptomatic improvement [ Time Frame: 2 months ] [ Designated as safety issue: No ]
|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)|
10mg orally four times per day
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).
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||David J Lederer, M.D.||Columbia University|