Domperidone in Treating Patients With Gastrointestinal Disorders (NCT01696734) | Clinical Trial Compass
RecruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
United States200 participantsStarted 2012-10-23
Plain-language summary
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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 signific…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline