Actively Recruiting
Domperidone in Treating Patients With Gastrointestinal Disorders
Led by M.D. Anderson Cancer Center · Updated on 2026-04-13
200
Participants Needed
1
Research Sites
783 weeks
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 phase III trial studies how well domperidone works in treating patients with gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating contraction of the stomach to increase its ability to empty itself of food.
CONDITIONS
Official Title
Domperidone in Treating Patients With Gastrointestinal Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with gastrointestinal disorders who have not responded to standard therapy
- Symptoms or signs of gastroparesis, refractory gastroesophageal reflux disease (including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms), or severe dyspepsia
- Completion of thorough evaluation including medical history and physical exam to rule out other causes
- Signed informed consent agreeing to the use of domperidone
- White blood cell count with differential above 3,000/ml
- Alkaline phosphatase less than 1.5 times the upper limit of normal
- Alanine aminotransferase (ALT) less than twice the upper limit of normal
- Aspartate aminotransferase (AST) less than twice the upper limit of normal
- Bilirubin less than or equal to twice the upper limit of normal
- Blood urea nitrogen (BUN) less than twice the upper limit of normal
- Creatinine less than 1.5 times the upper limit of normal
- Stable hemoglobin level at least 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...
- History of serious heart rhythm problems such as ventricular tachycardia, fibrillation, Torsade des Pointes, bradycardia, sinus node dysfunction, heart block, or prolonged QTc interval (over 450 ms for males, over 470 ms for females)
- Significant heart diseases including valvular heart disease needing medication, ischemic or pulmonary heart disease, cardiomyopathy, or heart failure
- Use of antiarrhythmic drugs that affect QTc interval
- Use of monoamine oxidase (MAO) inhibitors
- History or active liver failure
- Significant electrolyte imbalances 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 bleeding or obstruction within the last 6 weeks
- Presence of prolactinoma (pituitary tumor releasing prolactin)
- Pregnancy or breastfeeding; women of childbearing potential must have negative pregnancy test within 30 days before treatment and agree to effective birth control or abstinence during the study
- Known allergy to domperidone
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Mehnaz Shafi
CONTACT
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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