Study of Domperidone Treatment for Adults with Gastrointestinal Disorders Including Gastroparesis, Refractory GERD, and Severe Dyspepsia

What this Trial Is About

This research aims to evaluate how well domperidone works in treating patients aged 16 and older with gastrointestinal disorders, including gastroparesis, refractory gastroesophageal reflux disease, severe dyspepsia, and related symptoms like pain, bloating, nausea, and vomiting. Domperidone may help by stimulating stomach contractions to improve food emptying. This is a phase III trial focused on gastrointestinal motility disorders in patients who have not responded to standard treatments. Participants receive domperidone orally three or four times daily. Treatment continues as long as the disease does not worsen and no unacceptable side effects occur. After stopping the study drug, participants are followed for at least 30 days to monitor their condition and any lasting effects. During the study, researchers assess symptom changes using the Gastroparesis Cardinal Symptom Index over eight weeks and track patients self-reported symptoms up to 30 days after treatment ends. They also monitor any side effects or toxicities for 30 days post-treatment. Participants undergo clinical evaluations, laboratory tests, and complete questionnaires throughout the study to provide detailed information on treatment effects and safety.

Domperidone in Treating Patients With Gastrointestinal Disorders