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

NCT06842966 | Recruiting Phase 2

• 1 other identifier: GIB-02-03-2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 17

Brief 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

Outcome Measures

Primary Outcomes (1)

• Average 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 (56)

• Change in the total score of gastrointestinal symptom severity according to the GSRS questionnaire on days 8, 15, 22, and 29 compared to baseline

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

• Response rate to therapy (proportion of patients in the group showing a reduction in pain/discomfort in the upper abdomen on the VAS by more than 30%) by day 29 compared to baseline

  Day 29 ± 1

• Response rate to therapy (proportion of patients in the group showing a reduction in pain/discomfort in the upper abdomen on the VAS by 50% or more) by day 29 compared to baseline

  Day 29 ± 1

• Change in manifestations of dyspeptic disorders according to the GSRS questionnaire scores on days 8, 15, 22, and 29 compared to baseline

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

• Change in quality of life based on the total score from the SF-36 questionnaire by day 29 compared to baseline

  Day 29 ± 1

Study Arms (4)

4-MUST, 128 mg

EXPERIMENTAL

Patients will receive 1 tablet of the drug 4-MUST (128 mg of trimebutine 4-methylumbelliferyl sulfate) and 2 placebo tablets three times a day.

Drug: 4-MUST; Drug: Placebo

4-MUST, 256 mg

EXPERIMENTAL

Patients will receive 2 tablets of the drug 4-MUST (256 mg of trimebutine 4-methylumbelliferyl sulfate) and 1 placebo tablet three times a day.

Drug: 4-MUST; Drug: Placebo

4-MUST, 384 mg

EXPERIMENTAL

Patients will receive 3 tablets of the drug 4-MUST (384 mg of trimebutine 4-methylumbelliferyl sulfate) three times a day.

Drug: 4-MUST

Placebo

PLACEBO COMPARATOR

Patients will receive 3 placebo tablets three times a day.

Drug: Placebo

Interventions

4-MUST DRUG

128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.

Also known as: trimebutine 4-methylumbelliferyl sulfate

4-MUST, 128 mg; 4-MUST, 256 mg; 4-MUST, 384 mg

Placebo DRUG

Placebo tablet.

4-MUST, 128 mg; 4-MUST, 256 mg; 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.
• Presence of established gastrointestinal diseases: Chronic cholecystitis (K81.1); Dyskinesia of the bile duct or gallbladder (K82.8).
• Presence of pain/discomfort in the upper abdomen combined with at least one of the following symptoms: Heartburn; Belching; Nausea; Abdominal bloating; Borborygmi (stomach rumbling); Flatulence; Constipation; 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.
• 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.
• Peptic ulcer disease, duodenal ulcer, erosive GERD.
• Toxic megacolon.
• Paralytic ileus.
• Gilbert's syndrome.
• Abdominal adhesion disease.
• Blood in stool, unexplained weight loss, fever, anemia.
• Inflammatory and erosive gastrointestinal diseases.
• Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.

You may not qualify if:

• Ineffectiveness of therapy. The therapy will be deemed ineffective if there is no clinical improvement by visit 3 (15±1 days of therapy) - persistence or increase in the severity of pain/discomfort in the upper abdomen on the VAS compared to baseline. If excluded, the patient will be assigned alternative treatment at the discretion of the investigator.
• 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.
• If the investigator judges that comtinued participation in the study would harm the patient.
• Pregnancy or the need for breastfeeding in the patient.
• Gross violation by the patient of the study protocol procedures outlined in the patient information sheet (PIS).
• Withdrawal of informed consent (patient's unwillingness to continue participation in the study).
• Loss of contact with the patient (inability to reach the patient via mobile and home phone (if applicable), as well as through a contact person; there must be at least three documented attempts to contact the patient).
• 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 (17)

State autonomous health care institution "Engels City Clinical Hospital No. 1"

Engel's, 413116, Russia

RECRUITING

Ivanovo Kuvaev Clinical Hospital

Ivanovo, 153025, Russia

RECRUITING

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

Professors' Clinic LLC.

Perm, 614070, Russia

RECRUITING

Limited Liability Company "Medical Center Eco-Safety"

Saint Petersburg, 19119, Russia

RECRUITING

Limited Liability Company "Energy of Health"

Saint Petersburg, 194156, Russia

RECRUITING

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

Saint Petersburg, 194358, Russia

RECRUITING

Limited Liability Company "Clinic Zvezdnaya"

Saint Petersburg, 196158, Russia

RECRUITING

Limited Liability Company "Meili"

Saint Petersburg, 199406, Russia

RECRUITING

State Budgetary Institution "St. Petersburg Research Institute of Emergency Care named after I.I. Djanelidze"

Saint Petersburg, Russia

RECRUITING

Private institution of higher education "Medical University 'Reavis'"

Samara, Russia

RECRUITING

Association "Regional Medical Center 'Open Medicine'"

Tolyatti, Russia

RECRUITING

LLC "Polyclinic Polimedika Veliky Novgorod"

Veliky Novgorod, Russia

RECRUITING

Limited Liability Company "Medical Center for Diagnosis and Prevention Plus"

Yaroslavl, 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 24, 2025
• Study Start: October 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (17)