Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia
NCT ID: NCT06842966
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2024-10-17
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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4-MUST, 128 mg
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.
4-MUST
128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.
Placebo
Placebo tablet.
4-MUST, 256 mg
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.
4-MUST
128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.
Placebo
Placebo tablet.
4-MUST, 384 mg
Patients will receive 3 tablets of the drug 4-MUST (384 mg of trimebutine 4-methylumbelliferyl sulfate) three times a day.
4-MUST
128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.
Placebo
Patients will receive 3 placebo tablets three times a day.
Placebo
Placebo tablet.
Interventions
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4-MUST
128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.
Placebo
Placebo tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Presence of established gastrointestinal diseases: Chronic cholecystitis (K81.1); Dyskinesia of the bile duct or gallbladder (K82.8).
3. 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.
4. Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
5. Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.
6. 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).
7. Signed and dated informed consent from.
1. Peptic ulcer disease, duodenal ulcer, erosive GERD.
2. Toxic megacolon.
3. Paralytic ileus.
4. Gilbert's syndrome.
5. Abdominal adhesion disease.
6. Blood in stool, unexplained weight loss, fever, anemia.
7. Inflammatory and erosive gastrointestinal diseases.
8. Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
9. Oncological diseases of the gastrointestinal tract (including past diagnoses).
10. History of gastrointestinal surgical procedures, including but not limited to endoscopic papillotomy and cholecystectomy, exept for appendectomy.
11. Use of prohibited therapy medications within 3 days prior to randomization.
12. History of mental illnesses.
13. Chronic heart failure IIb-III stages and/or III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.
14. Chronic kidney disease stage IIIa-V (according to NKF/KDOQI, 2006).
15. 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.
16. HIV, syphilis, viral hepatitis B or C, including in history.
17. Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.
18. Liver cirrhosis.
19. Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.
20. Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen their prognosis and make it impossible for the patient to participate in clinical research).
21. Diabetes mellitus in a state of subcompensation and decompensation.
22. Systemic connective tissue diseases.
23. Autoimmune diseases.
24. Need for surgical and/or endovascular treatment and/or necessity for hemodialysis procedures.
25. Epilepsy or seizures of unclear etiology, including in history.
26. Alcoholism, substance abuse or drug addiction, including in history.
27. Uncorrected electrolyte disturbances.
28. History of surgery within 6 month prior to screening.
29. Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.
30. Patients who require prohibited concomitant therapy within this study framework.
31. Participation in another clinical trial within the last 3 months prior to the screening visit date.
32. Lack of willingness to cooperate from the patient's side.
33. Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.
Exclusion Criteria
3. Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
4. Requirement for prohibited concomitant therapy.
5. If the investigator judges that comtinued participation in the study would harm the patient.
6. Pregnancy or the need for breastfeeding in the patient.
7. Gross violation by the patient of the study protocol procedures outlined in the patient information sheet (PIS).
8. Withdrawal of informed consent (patient's unwillingness to continue participation in the study).
9. 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).
10. 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.
11. Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.
18 Years
70 Years
ALL
No
Sponsors
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Valenta Pharm JSC
INDUSTRY
Responsible Party
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Locations
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State autonomous health care institution "Engels City Clinical Hospital No. 1"
Engel's, , Russia
Ivanovo Kuvaev Clinical Hospital
Ivanovo, , Russia
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
Professors' Clinic LLC.
Perm, , Russia
Limited Liability Company "Medical Center Eco-Safety"
Saint Petersburg, , Russia
Limited Liability Company "Energy of Health"
Saint Petersburg, , Russia
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
Saint Petersburg, , Russia
Limited Liability Company "Clinic Zvezdnaya"
Saint Petersburg, , Russia
Limited Liability Company "Meili"
Saint Petersburg, , Russia
State Budgetary Institution "St. Petersburg Research Institute of Emergency Care named after I.I. Djanelidze"
Saint Petersburg, , Russia
Private institution of higher education "Medical University 'Reavis'"
Samara, , Russia
Association "Regional Medical Center 'Open Medicine'"
Tolyatti, , Russia
LLC "Polyclinic Polimedika Veliky Novgorod"
Veliky Novgorod, , Russia
Limited Liability Company "Medical Center for Diagnosis and Prevention Plus"
Yaroslavl, , Russia
Countries
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Facility Contacts
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Other Identifiers
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GIB-02-03-2024
Identifier Type: -
Identifier Source: org_study_id
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