A Prospective Multicenter Randomized Double-blind Placebo-controlled Study in Parallel Groups to Evaluate the Efficacy, Safety, and Tolerability of the Drug 4-MUST, Tablets, 128 mg, When Administered at Various Doses to Patients With Chronic Cholecystitis and Biliary Dyskinesia
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A study of the efficacy, safety, and tolerability of the drug 4-MUST at various doses compared to placebo in patients with chronic cholecystitis and biliary dyskinesia
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Men and women 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 not sexually active, or women using effective contraception methods (intrauterine devices, oral contraceptives, contraceptive patches, long-acting injectable contraceptives, double barrier methods) for 8 weeks prior to and during 3 weeks after the end of the study and have a negative pregnancy test, as well as women unable to conceive (documented conditions: hysterectomy, tubal ligation, infertility, 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).
• Presence of a signed and dated informed consent from the patient to participate in the study.
Locations
Other Locations
Russian Federation
State autonomous health care institution Engels City Clinical Hospital No. 1
RECRUITING
Engels
Ivanovo Kuvaev Clinical Hospital
RECRUITING
Ivanovo
State Budgetary Institution of Healthcare of Moscow City Polyclinic No. 2 of the Moscow Department of Healthcare
RECRUITING
Moscow
The State Budgetary Healthcare Institution of the Moscow Region Moscow Regional Research Clinical Institute named after M.F. Vladimirsky
RECRUITING
Moscow
Unimed-C Jsc
RECRUITING
Moscow
Limited Liability Company ErSi Medical
RECRUITING
Novosibirsk
Professors' Clinic LLC.
RECRUITING
Perm
Limited Liability Company Clinic Zvezdnaya
RECRUITING
Saint Petersburg
Limited Liability Company Energy of Health
RECRUITING
Saint Petersburg
Limited Liability Company Meili
RECRUITING
Saint Petersburg
St. Petersburg State Budgetary Healthcare Institution City Polyclinic No. 117
RECRUITING
Saint Petersburg
State Budgetary Institution St. Petersburg Research Institute of Emergency Care named after I.I. Djanelidze
RECRUITING
Saint Petersburg
Private institution of higher education Medical University 'Reavis'
RECRUITING
Samara
Limited Liability Company Medical Center Eco-Safety
RECRUITING
St. Petersburg
Association Regional Medical Center 'Open Medicine'
RECRUITING
Tol'yatti
LLC Polyclinic Polimedika Veliky Novgorod
RECRUITING
Veliky Novgorod
Limited Liability Company Medical Center for Diagnosis and Prevention Plus
RECRUITING
Yaroslavl
Time Frame
Start Date:2024-10-17
Estimated Completion Date:2026-12-31
Participants
Target number of participants:300
Treatments
Experimental: Group 1
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.
Experimental: Group 2
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.
Experimental: Group 3
Patients will receive 3 tablets of the drug 4-MUST (384 mg of trimebutine 4-methylumbelliferyl sulfate) three times a day.
Placebo_comparator: Group 4
Patients will receive 3 placebo tablets three times a day.