Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2012

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).

Intervention(s) in this Clinical Trial

• Drug: domperidone
  • 10mg orally four times per day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Domperidone

Primary Measures

• Symptomatic improvement
  • Time Frame: 2 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Columbia University

Overall Clinical Trial Officials and Contacts

David J Lederer, M.D. Principal Investigator Columbia University  

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

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00552422

Study ID Number: AAAC3728

ClinicalTrials.gov Identifier: NCT00552422

Health Authority: United States: Food and Drug Administration