Actively Recruiting
Treatment Protocol for the Compassionate Use of Domperidone for Gastrointestinal Disorders
Led by M.D. Anderson Cancer Center · Updated on 2026-04-13
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how well domperidone works in treating patients aged 16 and older with gastrointestinal disorders, including gastroparesis, refractory gastroesophageal reflux disease, severe dyspepsia, and related symptoms like pain, bloating, nausea, and vomiting. Domperidone may help by stimulating stomach contractions to improve food emptying. This is a phase III trial focused on gastrointestinal motility disorders in patients who have not responded to standard treatments. Participants receive domperidone orally three or four times daily. Treatment continues as long as the disease does not worsen and no unacceptable side effects occur. After stopping the study drug, participants are followed for at least 30 days to monitor their condition and any lasting effects. During the study, researchers assess symptom changes using the Gastroparesis Cardinal Symptom Index over eight weeks and track patients' self-reported symptoms up to 30 days after treatment ends. They also monitor any side effects or toxicities for 30 days post-treatment. Participants undergo clinical evaluations, laboratory tests, and complete questionnaires throughout the study to provide detailed information on treatment effects and safety.
CONDITIONS
Brief Title
Domperidone in Treating Patients With Gastrointestinal Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with gastrointestinal disorders who have failed standard therapy
- Symptoms or manifestations of gastroparesis, refractory gastroesophageal reflux disease including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms, or severe dyspepsia
- Completion of a comprehensive evaluation including clinical history and physical exam to rule out other causes of symptoms
- Signed informed consent agreeing to use of domperidone
- White blood cell count greater than 3,000/ml
- Alkaline phosphatase less than 1.5 times the upper limit of normal
- Alanine aminotransferase less than 2 times the upper limit of normal
- Aspartate aminotransferase less than 2 times the upper limit of normal
- Bilirubin less than or equal to 2 times the upper limit of normal
- Blood urea nitrogen less than 2 times the upper limit of normal
- Creatinine less than 1.5 times the upper limit of normal
- Stable hemoglobin greater than or equal to 8.0 g/dl
- Potassium level between 3.0 and 5.5
- Magnesium level between 1.6 and 2.6 mg
You will not qualify if you...
- Cardiac diagnoses including ventricular tachycardia or fibrillation, Torsade des Pointes, significant bradycardia, sinus node dysfunction, heart block, prolonged QTc interval above 450 ms for males or 470 ms for females, significant valvular heart disease, ischemic or pulmonary heart disease, cardiomyopathy, and history of heart failure
- Use of antiarrhythmic medications that prolong QTc interval such as amiodarone, disopyramide, dofetilide, flecainide, ibutilide, quinidine, sotalol, or dronedarone
- Use of monoamine oxidase (MAO) inhibitors
- History of or active liver failure
- Significant electrolyte disorders including sodium less than 130 or greater than 145, potassium less than 3.0 or greater than 5.5, or magnesium less than 1.6 or greater than 2.6
- Gastrointestinal hemorrhage or obstruction within the past 6 weeks
- Presence of a prolactinoma (pituitary tumor releasing prolactin)
- Pregnant or breastfeeding females; women of childbearing potential must have a negative pregnancy test and use effective birth control during the study
- Known allergy to domperidone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or unacceptable toxicity
Participants receive domperidone orally three or four times daily. Treatment continues as long as there is no disease progression or unacceptable toxicity.
Visits as needed during treatment
Duration - At least 30 days
Participants are followed up for at least 30 days after completing study treatment to monitor symptoms and any toxicities.
1 to 2 visits depending on participant status
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Mehnaz Shafi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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