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Domperidone for Gastrointestinal Disorders
Study Summary
This trial looks at how well domperidone works to treat gastrointestinal disorders. Domperidone may help control symptoms like pain, bloating, and nausea and vomiting, by stimulating the stomach to empty itself of food.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am taking medication that affects my heart's rhythm.I have a history of or currently have liver failure.I am not pregnant or breastfeeding, and if capable of becoming pregnant, I agree to use birth control during the study.I have severe stomach or esophagus problems like gastroparesis, GERD, or dyspepsia.I have a history of serious heart conditions.You are allergic to domperidone.My GI disorder hasn't improved with standard treatments.I have agreed to take the study drug, domperidone, by signing a consent form.Your alkaline phosphatase level is lower than 1.5 times the normal limit.Your hemoglobin level is at least 8.0 grams per deciliter and not changing.Your ALT level is not more than two times the upper limit of normal.I have severe stomach or esophagus problems, like gastroparesis or bad heartburn.I have severe stomach issues like gastroparesis, GERD, or dyspepsia.Your blood urea nitrogen level is not too low.My GI disorder hasn't improved with standard treatments.Your hemoglobin level is at least 8.0 grams per deciliter and has not changed significantly.Your blood urea nitrogen (BUN) level is not too low.I have not had any GI bleeding or blockage in the last 6 weeks.I have a tumor in my pituitary gland that releases prolactin.I have signed the consent form to use the study drug, domperidone.Your liver enzyme levels are not too high.Your AST blood test result is not more than twice the upper limit of normal.Your magnesium level is between 1.6 and 2.6 mg.Your creatinine levels are within a certain range.Your bilirubin levels are not more than twice the normal limit.Your magnesium level is between 1.6 and 2.6 mg.Your AST levels are not more than twice the upper limit of normal.Your bilirubin levels are no higher than twice the upper limit of normal.I am currently taking MAO inhibitors.Your white blood cell count is higher than 3,000 per milliliter.Your white blood cell count is higher than 3,000 per milliliter.Your alkaline phosphatase levels are lower than 1.5 times the normal range.My GI disorder hasn't improved with standard treatments.Your potassium levels are between 3.0 and 5.5.Your creatinine levels are within a certain range.Your potassium levels should be between 3.0 and 5.5.Your sodium, potassium, or magnesium levels in the blood are too low or too high.
- Group 1: Treatment (domperidone)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any documented dangers of taking Domperidone?
"Domperidone's Phase 3 status signifies that, while there is some efficacy data, the drug has undergone multiple rounds of testing for safety. Therefore, our team at Power has given it a score of 3 for safety."
Could you inform me as to how many people are included in this experiment?
"That is accurate. The clinical trial was first posted on October 23, 2012 and is still actively recruiting patients, as indicated by the most recent edit on October 18, 2022. They are looking for 200 participants total, at a single location."
Are there other examples of research regarding Domperidone?
"There are 4 ongoing studies evaluating Domperidone's efficacy. 1 of those trials is in the final stage of testing, Phase 3. The remaining trials are based in Bangkok, but there are 4 locations total running these studies."
For what therapeutic reasons is Domperidone typically prescribed?
"Domperidone is used to treat a variety of upper gastrointestinal motility disorders, including gastroparesis, esophagitis, and gastroesophageal reflux disease."
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