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New treatment option for Digestive System Disorder
Official title Domperidone in Treating Patients With Gastrointestinal Disorders
ClinicalTrials.gov ID: NCT01696734
What this study is testing
What is Domperidone?
Domperidone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for digestive system disorder.
Also referred to as KW 5338, Motilium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsade des Pointes; clinically significant bradycardia...
- Patients who are receiving antiarrhythmic medications with action on repolarization times (with prolongation of the QTc interval such as amiodarone...
- Patients who are receiving monoamine oxidase (MAO) inhibitors
- Patients with a history of or active liver failure
- Clinically significant electrolyte disorders including sodium \ 145 and/or potassium \ 5.5 and/or magnesium \ 2.6
- GI hemorrhage or obstruction experienced within the previous 6 weeks
See the full eligibility 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)...
- 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
- 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...
- 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...
- Patients who are receiving monoamine oxidase (MAO) inhibitors
- Patients with a history of or active liver failure
- Clinically significant electrolyte disorders including sodium \ 145 and/or potassium \ 5.5 and/or magnesium \ 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...
- Known allergy to domperidone
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.