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Domperidone for Gastrointestinal Disorders

This study is testing how well domperidone works for people with gastrointestinal (GI) disorders. Domperidone is a medication that may help control chronic GI symptoms like pain, bloating, nausea, and vomiting by stimulating the stomach to empty food more effectively. You may be able to join if you are 16 or older, have a GI disorder that hasn't improved with standard treatments, and experience symptoms like gastroparesis (stomach paralysis), severe indigestion (dyspepsia), or difficult-to-treat acid reflux (GERD). The main goal is to see if domperidone can reduce your GI symptoms, measured by changes in your Gastroparesis Cardinal Symptom Index (GSCI) score over 8 weeks. The current status of this study is unclear, and it aims to enroll 200 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to enroll 200 participants.
What's involved
You would take domperidone by mouth either three or four times daily. You will also complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
After completing the study treatment, you will be followed for at least 30 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01696734

Domperidone in Treating Patients With Gastrointestinal Disorders

Recruiting
PHASE3Ages 16+Interventional
M.D. Anderson Cancer Center
~200 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:DomperidoneQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline
Measured over Baseline to 8 weeks

Conditions

Digestive System Disorder
Dyspepsia
Esophagitis
Gastroesophageal Reflux Disease
Gastroparesis
Heartburn
Nausea and Vomiting

Explore related trials

Digestive System DisorderDyspepsiaEsophagitisGastroesophageal Reflux DiseaseGastroparesisHeartburnNausea and Vomiting

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Mehnaz Shafi · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Mehnaz Shafi
[email protected]
713-794-5073
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with GI disorders who have failed standard therapy
Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia
Completion of a comprehensive evaluation, including clinical history and physical examination, to eliminate other causes of their symptoms
Patient has signed the informed consent document agreeing to the use of the study drug, domperidone
White blood cell (WBC) with differential greater than 3,000/ml
Alkaline phosphatase less than 1.5 x upper limit of normal
Alanine aminotransferase (ALT) less than 2 x upper limit of normal
Aspartate aminotransferase (AST) less than 2 x upper limit of normal
Bilirubin less than or equal to 2 x upper limit of normal
Blood urea nitrogen (BUN) less than 2 x upper limit of normal
Creatinine less than 1.5 x upper limit of normal
Stable hemoglobin greater than or equal to 8.0 g/dl
Potassium between range of 3.0 to 5.5
Magnesium level between 1.6-2.6 mg

Exclusion

Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsade des Pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged QTc interval (QTc \> 450 milliseconds for males, QTc \> 470 milliseconds for females); prior specific cardiovascular conditions of clinically significant valvular heart disease requiring medication, ischemic, or pulmonary heart disease; cardiomyopathy; history of heart failure
Patients who are receiving antiarrhythmic medications with action on repolarization times (with prolongation of the QTc interval such as amiodarone, disopyramide, dofetilide, flecainide, ibutilide, quinidine, sotalol, dronedarone etc.)
Patients who are receiving monoamine oxidase (MAO) inhibitors
Patients with a history of or active liver failure
Clinically significant electrolyte disorders including sodium \< 130 or \> 145 and/or potassium \< 3.0 or \> 5.5 and/or magnesium \< 1.6 or \> 2.6
GI hemorrhage or obstruction experienced within the previous 6 weeks
Presence of a prolactinoma (prolactin-releasing pituitary tumor)
Pregnant or breast-feeding female (women of childbearing potential \[WOCBP\], defined as not post-menopausal for 12 months or without previous surgical sterilization, must have a negative urine pregnancy test within 30 days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)
Known allergy to domperidone

What this trial measures

  • Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baselineBaseline to 8 weeks

    Scale ranges from "0" meaning "None" to "5" meaning "Very Severe". Patients will be classified as either "new" or "continuing" at the baseline visit. A new patient will have a "response" if he/she has a 25% reduction in GCSI at 8 weeks. A continuing patient will already have early benefit to treatment so will have a "response" if the GCSI score does not increase more than 20% over baseline at 8 weeks. Summary statistics including number (n), mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.