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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Cholecystitis, Biliary Dyskinesia

In brief

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.

Key facts

Study ID: NCT07595003
Run by: Valenta Pharm JSC
People needed: 300
Starts: 2025-12-12
Expected to finish: 2027-12-31
Last updated by the study team: 2026-05-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.
Non-inclusion Criteria:
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.
Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
Gastrointestinal malignancy (including history of) or suspected gastrointestinal malignancy (e.g., blood in stool, unexplained weight loss, fever, anemia).
Any other oncological diseases known at the time of screening, or suspicion thereof.
History of gastrointestinal surgery, including cholecystectomy or endoscopic sphincterotomy (appendectomy excluded).
Use of prohibited therapy medications within 3 days prior to randomization.
History of mental illnesses.
Chronic heart failure IIb-III stages and/or III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.
Chronic kidney disease stage IIIa-V (according to NKF/KDOQI, 2006).
History of or current hepatic impairment; or liver test abnormalities: AST, ALT, ALP, or GGT >3 above the upper limit of normal (ULN); total bilirubin >2 ULN or clinical jaundice.

You may not qualify if…

Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
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.

Where it is running

State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare" — Moscow, Russia (enrolling)
Unimed-C Jsc — Moscow, Russia (enrolling)
The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky" — Moscow, Russia (enrolling)
Limited Liability Company "ErSi Medical" — Novosibirsk, Russia (enrolling)
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 (enrolling)
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117" — Saint Petersburg, Russia (enrolling)
Limited Liability Company "Research Center Eco-Safety" — Saint Petersburg, Russia (enrolling)
Limited Liability Company "Research Center Eco-Safety" — Saint Petersburg, Russia (enrolling)
Limited Liability Company "Clinic Zvezdnaya" — Saint Petersburg, Russia (enrolling)
State Healthcare Institution "Saratov City Clinical Hospital No. 5" — Saratov, Russia (enrolling)

Full record on ClinicalTrials.gov

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