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

ClinicalTrials.gov ID

NCT07595003

Lead Sponsor

Valenta Pharm JSCINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

300Estimated

Last Update Posted

May 19, 2026Actual

Start Date

Dec 12, 2025Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

Official Title

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Patients With Chronic Cholecystitis and Biliary Tract Dyskinesia

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.

• Chronic Cholecystitis
• Biliary Dyskinesia

• 4-MUST
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Males and females aged 18-70 years.
2. 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.
3. 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.
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. The total bilirubin level does not exceed 2 times the upper limit of normal (no more than 42 μmol/L).
7. 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).
8. Signed and dated informed consent from.

Non-inclusion Criteria:

1. 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.
2. Indication for surgical or endoscopic intervention due to exacerbation of chronic cholecystitis or complications of biliary tract dyskinesia.
3. Toxic megacolon.
4. Paralytic ileus.
5. Gilbert's syndrome.
6. Choledocholithiasis (or a high risk of its development, as determined by the investigator);
7. Impaired bile outflow due to adhesions in the abdominal cavity.Abdominal adhesion disease.
8. Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
9. Gastrointestinal malignancy (including history of) or suspected gastrointestinal malignancy (e.g., blood in stool, unexplained weight loss, fever, anemia).
10. Any other oncological diseases known at the time of screening, or suspicion thereof.
11. History of gastrointestinal surgery, including cholecystectomy or endoscopic sphincterotomy (appendectomy excluded).
12. Use of prohibited therapy medications within 3 days prior to randomization.
13. History of mental illnesses.
14. Chronic heart failure IIb-III stages and/or III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.
15. Chronic kidney disease stage IIIa-V (according to NKF/KDOQI, 2006).
16. 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.
17. HIV, syphilis, viral hepatitis B or C, including in history.
18. Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.
19. Liver cirrhosis.
20. Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.
21. Severe, decompensated, or unstable somatic conditions that are life-threatening, worsen prognosis, or preclude safe study participation.
22. Diabetes mellitus in a state of subcompensation and decompensation.
23. Systemic connective tissue diseases.
24. Autoimmune diseases.
25. Indication for hemodialysis procedures.
26. Epilepsy or seizures of unclear etiology, including in history.
27. Alcoholism, substance abuse or drug addiction, including in history.
28. Uncorrected electrolyte disturbances.
29. QTcF interval on a 12-lead electrocardiogram (ECG) ≥430 ms in men and ≥450 ms in women.
30. Episodes of constipation during the last 3 months that required the prescription of drug therapy.
31. History of surgery within 6 month prior to screening.
32. Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.
33. Patients who require prohibited concomitant therapy within this study framework.
34. Participation in another clinical trial within the last 3 months prior to the screening visit date.
35. Unwillingness or inability to comply with study procedures and protocol requirements..
36. Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.

Exclusion Criteria:

1. Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
2. 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.
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. Use of Duspatalin® (INN: mebeverine) for more than 3 consecutive days or for more than 5 days in total throughout the study.
6. If the investigator judges that comtinued participation in the study would harm the patient.
7. Pregnancy or the need for breastfeeding.
8. Major protocol deviation by the subject with respect to procedures outlined in the Informed Consent Form (ICF).
9. Withdrawal of informed consent by the subject (decision to discontinue study participation).
10. Lost to follow-up: Inability to contact the subject after ≥3 documented attempts via mobile phone, landline (if applicable), and designated emergency contact.
11. 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.
12. Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Valenta Pharm JSCINDUSTRY

orlelik@mail.ru+7 (919) 994-90-14

annkosheleva86@gmail.com+7-913-470-70-67

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

  NCT06842966

  RecruitingInterventionalPhase 2Updated Jul 11, 2025
• Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers

  NCT07594977

  RecruitingInterventionalPhase 1Updated Jun 15, 2026
• Safety, Tolerability and Pharmacokinetics of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Multiple Oral Administration in Healthy Volunteers

  NCT06315387

  Unknown statusInterventionalPhase 1Updated Mar 18, 2024
• Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg

  NCT06342804

  Unknown statusInterventionalPhase 1Updated Apr 2, 2024
• MITE in the Treatment of Dyspepsia After Cholecystectomy

  NCT04786795

  Unknown statusInterventionalPhase 4Updated Mar 8, 2021
• Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.

  NCT07421011

  RecruitingInterventionalPhase 1Updated Feb 19, 2026