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

NCT07595003 | Recruiting Phase 3

• 1 other identifier: GIB-03-04-2025
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Chronic Cholecystitis; Biliary Dyskinesia

Outcome Measures

Primary Outcomes (1)

• Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline

  Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"

  Day 29 ± 1

Secondary Outcomes (65)

• Mean reduction in the severity of pain/discomfort in the upper abdomen according to VAS by days 2-28 from the start of therapy

  Day 2 - Day 28

• Frequency of response to therapy (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more) by days 8, 15, 22, and 29 following treatment initiation.

  Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1

• Frequency of response to therapy (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more) by days 8, 15, 22, and 29 following treatment initiation.

  Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1

• Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more)

  Day 29 ± 1

• Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more)

  Day 29 ± 1

Study Arms (2)

4-MUST

EXPERIMENTAL

4-MUST: 384 mg (3 tablets), orally three times a day (TID), 30 min before meals. Total daily dose - 1152 mg.

Drug: 4-MUST

Placebo

PLACEBO COMPARATOR

Placebo: 3 tablets, orally three times a day (TID), 30 min before meals.

Drug: Placebo

Interventions

4-MUST DRUG

128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.

Also known as: trimebutine 4-methylumbelliferyl sulfate

4-MUST

Placebo DRUG

Placebo tablet.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 18-70 years.
• Diagnosed with chronic cholecystitis (K81.1) and/or dyskinesia of the cystic duct or gallbladder (K82.8) prior to enrollment; diagnosis supported by clinical history of exacerbations and remissions and/or imaging/laboratory findings.
• Upper abdominal pain or discomfort attributable to gallbladder or biliary tract dysfunction (per investigator assessment), accompanied by ≥1 of the following: heartburn, belching, nausea, abdominal bloating, borborygmi (stomach rumbling), flatulence, constipation, or diarrhea.
• Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
• Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.
• The total bilirubin level does not exceed 2 times the upper limit of normal (no more than 42 μmol/L).
• Women who are either sexually abstinent or using effective contraception methods (e.g. intrauterine devices, contraceptive patches, long-acting injectable contraceptives, or double barrier methods) for at least 8 weeks before and 3 weeks after the end of the study, with a confirmed negative pregnancy test, as well as women with documented infertility or non-childbearing status (e.g. hysterectomy, tubal ligation, infertility or menopause for more than 1 year) or men using barrier contraceptives throughout the study and for 3 weeks after its completion, or men unable to conceive (documented conditions: vasectomy, infertility).
• Signed and dated informed consent from.
• Gastric or duodenal ulcer, erosive gastroesophageal reflux disease (GERD), or other inflammatory/erosive gastrointestinal diseases in the acute stage, unless stable remission for ≥ 1 year since the last exacerbation.
• Indication for surgical or endoscopic intervention due to exacerbation of chronic cholecystitis or complications of biliary tract dyskinesia.
• Toxic megacolon.
• Paralytic ileus.
• Gilbert's syndrome.
• Choledocholithiasis (or a high risk of its development, as determined by the investigator);
• Impaired bile outflow due to adhesions in the abdominal cavity.Abdominal adhesion disease.

You may not qualify if:

• Lack of Efficacy. Study treatment will be discontinued if no clinical improvement is observed by Visit 3 (Day 15 ± 1), defined as persistence or worsening of upper abdominal pain/discomfort (assessed by Visual Analog Scale \[VAS\]) compared to baseline. Upon discontinuation, alternative therapy will be initiated at the investigator's discretion.
• Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
• Requirement for prohibited concomitant therapy.
• Use of Duspatalin® (INN: mebeverine) for more than 3 consecutive days or for more than 5 days in total throughout the study.
• If the investigator judges that comtinued participation in the study would harm the patient.
• Pregnancy or the need for breastfeeding.
• Major protocol deviation by the subject with respect to procedures outlined in the Informed Consent Form (ICF).
• Withdrawal of informed consent by the subject (decision to discontinue study participation).
• Lost to follow-up: Inability to contact the subject after ≥3 documented attempts via mobile phone, landline (if applicable), and designated emergency contact.
• Emergence during the study of any diseases or conditions that worsen the patient's prognosis, making it impossible for the patient to continue participating in this clinical trial.
• Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (10)

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

Moscow, 117556, Russia

RECRUITING

Unimed-C Jsc

Moscow, 119571, Russia

RECRUITING

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

Moscow, Russia

RECRUITING

Limited Liability Company "ErSi Medical"

Novosibirsk, Russia

RECRUITING

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, 614990, Russia

RECRUITING

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

Saint Petersburg, 194358, Russia

RECRUITING

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

RECRUITING

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

RECRUITING

Limited Liability Company "Clinic Zvezdnaya"

Saint Petersburg, 196158, Russia

RECRUITING

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

Saratov, 410071, Russia

RECRUITING

MeSH Terms

Conditions

Biliary Dyskinesia

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-03

Locations

RU (10)