Clinical Trial

Trimebutine Maleate for Enhancing Gastric Visualization in Acute Upper Gastrointestinal Bleeding

Not Yet Recruiting Phase 2/3
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Summary
Acute upper gastrointestinal bleeding is a medical emergency that requires an urgent upper endoscopy to locate and treat the source of the bleeding. Often, retained blood and clots in the stomach make it difficult for the endoscopist to clearly see the stomach's anatomical structures. This study aims to evaluate if administering a medication called Trimebutine Maleate before the endoscopy can help empty the stomach of residual blood and improve the doctor's view. Trimebutine Maleate is a widely prescribed medication that regulates gastrointestinal movement and has a favorable safety profile compared to other medications used for this purpose. Researchers will include 100 adult patients experiencing acute upper gastrointestinal bleeding who are scheduled for an urgent endoscopy within 24 hours of presentation. Participants will be randomly assigned to receive either 50 mg of intravenous Trimebutine Maleate or a matching placebo (saline solution) 60 to 90 minutes before their procedure. All participants will continue to receive standard medical treatment for their bleeding according to normal hospital protocols. The primary goal of the study is to compare the clarity of the stomach view between the two groups using a standardized Gastric Visualization Score. The research team will also measure how often the exact bleeding source is successfully identified, the total duration of the procedure, and whether patients require a repeat endoscopy or a stomach washout (gastric lavage).
Trial Details
NCT Number NCT07749300
Lead Sponsor Assiut University
Conditions Acute Upper Gastrointestinal Bleeding, Upper Gastrointestinal Bleeding, Gastrointestinal Hemorrhage
Enrollment 100 participants
Start Date 2026-09
Primary Completion 2027-09 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-06