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RECRUITING
NCT07595003
PHASE3

Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Chronic Cholecystitis and Biliary Dyskinesia

Sponsor: Valenta Pharm JSC

View on ClinicalTrials.gov

Summary

The aim of the study is to evaluate the efficacy, safety, and tolerability of 4-MUST, 128 mg tablets compared to placebo in patients with chronic cholecystitis and biliary dyskinesia.

Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Patients With Chronic Cholecystitis and Biliary Tract Dyskinesia

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-12-12

Completion Date

2027-12-31

Last Updated

2026-05-19

Healthy Volunteers

No

Interventions

DRUG

4-MUST

128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.

DRUG

Placebo

Placebo tablet.

Locations (10)

State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"

Moscow, Russia

Unimed-C Jsc

Moscow, Russia

The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"

Moscow, Russia

Limited Liability Company "ErSi Medical"

Novosibirsk, Russia

Federal State Budgetary Educational Institution of Higher Education "Academician E.A. Wagner Perm State Medical University" of the Ministry of Healthcare of the Russian Federation

Perm, Russia

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"

Saint Petersburg, Russia

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, Russia

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, Russia

Limited Liability Company "Clinic Zvezdnaya"

Saint Petersburg, Russia

State Healthcare Institution "Saratov City Clinical Hospital No. 5"

Saratov, Russia