Domperidone for Gastroparesis in Solid Organ Transplantation

Gastroesophageal Reflux Clinical Trial

Official title: Domperidone for Gastroparesis Associated With Solid Organ Transplantation

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroparesis

• NCT number: NCT00552422
• Study type: Interventional
• Source: Columbia University
• Status: Terminated
• Phase: N/A
• Start date: March 2007
• Completion date: September 2010