Domperidone for Gastroparesis in Solid Organ Transplantation

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

Detailed Description
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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).

Official Title
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Domperidone for Gastroparesis Associated With Solid Organ Transplantation

Conditions
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Gastroparesis, Gastroesophageal Reflux

Intervention / Treatment
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* Drug: domperidone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Domperidone Arm<br>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. | Drug: domperidone<br>* 10mg orally four times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic Improvement | The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastroparesis, gastroesophageal reflux