Domperidone for Gastroparesis in Solid Organ Transplantation

NCT ID: NCT00552422

Last Updated: 2015-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-09-30

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).

Conditions

Gastroparesis; Gastroesophageal Reflux

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

domperidone

Intervention Type: DRUG

10mg orally four times per day

Interventions

domperidone

10mg orally four times per day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

David J. Lederer, M.D.

OTHER

Sponsor Role: lead

Responsible Party

David J. Lederer, M.D.

Herbert Irving Assistant Professor of Medicine and Epidemiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David J Lederer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAC3728

Identifier Type: -

Identifier Source: org_study_id