Trimebutine Maleate for Enhancing Gastric Visualization in Acute Upper Gastrointestinal Bleeding

NCT07749300 | Not Yet Recruiting Phase 2

• 1 other identifier: Trimebutine for UGIB Endoscopy
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Trimebutine Maleate; Trimebutine; Gastric Visualization; Endoscopy; Esophagogastroduodenoscopy

Outcome Measures

Primary Outcomes (1)

• Total Gastric Visualization Score

  Gastric visualization will be assessed by the endoscopist across five anatomical areas: the fundus, upper body, lower body, antrum, and duodenum. Each area is evaluated using a 4-point scale: 0 (large amount of blood/clots obscuring vision), 1 (moderate blood requiring suction), 2 (small amount of blood with adequate visualization), and 3 (excellent visualization). The scores from all five areas are summed to create a Total Gastric Visualization Score ranging from 0 to 15, with higher scores indicating better visualization.

  60 to 90 minutes post-intervention

Secondary Outcomes (1)

• Identification Rate of Bleeding Source

  60 to 90 minutes post-intervention

Study Arms (2)

Trimebutine Maleate Group

EXPERIMENTAL

Participants in this group will receive an intravenous administration of 50 mg Trimebutine Maleate approximately 60 to 90 minutes prior to their scheduled urgent upper gastrointestinal endoscopy. All patients will also receive standard medical treatment for acute upper gastrointestinal bleeding according to institutional protocols.

Drug: Trimebutine Maleate

Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive a matching placebo, consisting of an ampoule of saline, administered approximately 60 to 90 minutes prior to their scheduled urgent upper gastrointestinal endoscopy. All patients will also receive standard medical treatment for acute upper gastrointestinal bleeding according to institutional protocols.

Other: Placebo

Interventions

Trimebutine Maleate DRUG

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

Trimebutine Maleate Group

Placebo OTHER

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

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Clinical evidence of AUGIB: Hematemesis, coffee-ground vomiting or melena.
• Planned urgent upper gastrointestinal endoscopy within 24 hours.

You may not qualify if:

• Known gastric outlet obstruction.
• Previous gastric surgery.
• Pregnancy or lactation.
• Allergy to Trimebutine Maleate.
• Chronic use of prokinetic medications.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Trimebutine

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxybenzoate Ethers; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Tropical Medicine and Gastroenterology

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08