NCT06842966

Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia

A Prospective Multicenter Randomized Double-blind Placebo-controlled Study in Parallel Groups to Evaluate the Efficacy, Safety, and Tolerability of the Drug 4-MUST, Tablets, 128 mg Administered at Various Doses in Patients With Chronic Cholecystitis and Biliary Dyskinesia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy, safety, and tolerability of the drug 4-MUST at various doses compared to placebo in patients with chronic cholecystitis and biliary dyskinesia

Conditions

• Chronic Cholecystitis
• Biliary Dyskinesia

Interventions

Type	Name	Description
DRUG	4-MUST	128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.
DRUG	Placebo	Placebo tablet.

Timeline

• Start date: 2024-10-17
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-24
• Last updated: 2025-07-11

Locations

17 sites across 1 country: Russia