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Trimebutine Maleate for Enhancing Gastric Visualization in Acute Upper Gastrointestinal Bleeding

NCT07749300 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-06

No results posted yet for this study

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).

Conditions

  • Acute Upper Gastrointestinal Bleeding
  • Upper Gastrointestinal Bleeding
  • Gastrointestinal Hemorrhage

Interventions

DRUG

Trimebutine Maleate

50 mg of Trimebutine Maleate administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.

OTHER

Placebo

A matching placebo consisting of an ampoule of saline administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2027-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07749300 on ClinicalTrials.gov