Could a common drug ease chronic stomach pain and nausea?
NCT ID NCT01696734
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether domperidone, a drug that helps the stomach empty food, can reduce symptoms like pain, bloating, nausea, and vomiting in people with chronic digestive disorders. About 200 patients who have not improved with standard treatments will take domperidone and report their symptom changes over 8 weeks. The goal is to see if the drug can provide relief for conditions such as gastroparesis, severe heartburn, and indigestion.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Domperidone
- What this could lead to
- If it works, this could provide a treatment option for people with chronic gastrointestinal disorders who have not been helped by standard therapies.
- What could go wrong
- This is an early-phase trial with only 200 participants, and it focuses on symptom improvement rather than a cure. Domperidone may cause side effects, and its long-term safety is not fully established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2012
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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