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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Chronic Cholecystitis, Biliary Dyskinesia

In brief

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

Key facts

Study ID: NCT06842966
Run by: Valenta Pharm JSC
People needed: 300
Starts: 2024-10-17
Expected to finish: 2026-12-31
Last updated by the study team: 2025-07-11

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.
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.
Non-inclusion Criteria:
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.
Oncological diseases of the gastrointestinal tract (including past diagnoses).
History of gastrointestinal surgical procedures, including but not limited to endoscopic papillotomy and cholecystectomy, exept for appendectomy.
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).
Established diagnosis of liver failure, including in history and/or changes in liver enzyme activity: Increase in AST, ALT, ALP and/or γ-GTP more than 3 times above the upper limit of normal; Increase in total bilirubin more than 2 times above the upper limit of normal or development of jaundice.
HIV, syphilis, viral hepatitis B or C, including in history.
Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.

You may not qualify if…

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

Where it is running

State autonomous health care institution "Engels City Clinical Hospital No. 1" — Engel's, Russia (enrolling)
Ivanovo Kuvaev Clinical Hospital — Ivanovo, Russia (enrolling)
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)
Professors' Clinic LLC. — Perm, Russia (enrolling)
Limited Liability Company "Medical Center Eco-Safety" — Saint Petersburg, Russia (enrolling)
Limited Liability Company "Energy of Health" — Saint Petersburg, Russia (enrolling)
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117" — Saint Petersburg, Russia (enrolling)
Limited Liability Company "Clinic Zvezdnaya" — Saint Petersburg, Russia (enrolling)
Limited Liability Company "Meili" — Saint Petersburg, Russia (enrolling)
State Budgetary Institution "St. Petersburg Research Institute of Emergency Care named after I.I. Djanelidze" — Saint Petersburg, Russia (enrolling)
Private institution of higher education "Medical University 'Reavis'" — Samara, Russia (enrolling)
Association "Regional Medical Center 'Open Medicine'" — Tolyatti, Russia (enrolling)
LLC "Polyclinic Polimedika Veliky Novgorod" — Veliky Novgorod, Russia (enrolling)
Limited Liability Company "Medical Center for Diagnosis and Prevention Plus" — Yaroslavl, Russia (enrolling)

Full record on ClinicalTrials.gov

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