Domperidone for Gastroparesis in Solid Organ Transplantation

Not Applicable

Terminated

• Conditions: Gastroesophageal Reflux; Gastroparesis
• Interventions: Drug: domperidone

• Registration Number: NCT00552422
• Lead Sponsor: David J. Lederer, M.D.

Brief Summary

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

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).

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-10-31
• Study First Posted: 2007-11-01
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2015-06
• Results First Submitted: 2015-06-02
• Results First Submitted QC: 2015-06-17
• Last Update Submitted: 2015-06-17
• Results First Posted: 2015-07-10
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Domperidone Arm	domperidone	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.

Primary Outcome Measures

Name	Time	Method
Symptomatic Improvement	2 months	The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States