Domperidone for Gastroparesis in Solid Organ Transplantation

Gastroesophageal Reflux Clinical Trial

Official title:

Domperidone for Gastroparesis Associated With Solid Organ Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00552422
• Other study ID #: AAAC3728
• Status: Terminated
• Phase: N/A
• First received: October 31, 2007
• Last updated: June 17, 2015
• Start date: March 2007
• Est. completion date: September 2010

Study information

• Verified date: June 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroparesis

Intervention

Drug:
• domperidone
10mg orally four times per day

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
David J. Lederer, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic Improvement	The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.	2 months	No