[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-dyskinesia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-dyskinesia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,66,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100642272","phase-1-food-effect-single-and-multiple-dose-pharmacokinetics-safety-and-tolerability-study-of-4-must-128-mg-tablets-in-healthy-volunteers-100642272",false,"NCT07594977","Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers","An Open-Label Study to Evaluate the Effect of Food on the Bioavailability of 4-MUST, 128 mg, Tablets and to Assess the Pharmacokinetics, Safety, and Tolerability Following Single and Multiple Dose Administration in Healthy Volunteers","Inclusion Criteria:\n\n* Voluntary, personally signed ICF obtained prior to any study procedures;\n* Males and females aged 18 to 45 years (inclusive) of Caucasian race;\n* Confirmed healthy status based on the absence of clinically significant abnormalities in clinical, laboratory, and diagnostic assessments specified in the protocol;\n* Blood pressure (BP): systolic blood pressure (SBP) from 99 to 129 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mmHg (inclusive);\n* Heart rate (HR) from 60 to 89 beats\u002Fmin (inclusive);\n* Respiratory rate (RR) from 12 to 20 per 1 minute (inclusive);\n* Body temperature from 36.0°C to 36.9°C (inclusive);\n* Body mass index (BMI) of 18.5 kg\u002Fm2 ≤ BMI ≤ 30 kg\u002Fm2, with body weight ≥ 55 kg for males and ≥ 45 kg for females;\n* Commitment to adhere to highly effective contraceptive methods during the study participation period and for 30 days thereafter; documentation of negative urine pregnancy test for women of childbearing potential.\n\nNoninclusion Criteria:\n\n* History of clinically significant allergic reactions;\n* Hypersensitivity to hymecromone and trimebutine and\u002For excipients included in the study drug in anamnesis;\n* Drug intolerance to hymecromone and trimebutine and\u002For excipients included in the study drug in the anamnesis;\n* Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption in the anamnesis;\n* Chronic diseases of the kidney, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary and immune systems, as well as skin, hematopoietic and visual organs;\n* History of GI surgery (except for appendectomy at least 1 year prior to screening);\n* Diseases\u002Fconditions that, in the opinion of the investigator, may affect the absorption, distribution, metabolism, or excretion of the study drug;\n* Acute infectious diseases less than 4 weeks prior to screening;\n* Intake of drugs that have a significant effect on hemodynamics and drugs that affect liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening;\n* Regular intake of a medicine less than 2 weeks prior to screening and single intake of a medicine less than 7 days prior to screening (including over-the-counter medicines, vitamins, supplements, herbs);\n* Blood or plasma donation less than 3 months prior to screening;\n* Use of hormonal contraceptives (in women) less than 2 months prior to screening;\n* Use of depot injections of any medicine less than 3 months prior to screening;\n* Pregnancy or lactation period; positive pregnancy test for women of childbearing potential;\n* Women of childbearing potential who have had unprotected sexual intercourse with a non-sterilized male partner within 30 days prior to administration of the study drug;\n* Participation in another clinical trial less than 3 months prior to screening or concurrent with the present study;\n* Consumption of more than 10 units of alcohol per week during the month prior to study enrollment (1 unit of alcohol is equivalent to 500 mL of beer, 200 mL of wine, or 50 mL of spirits), or a history of alcoholism, drug dependence, or abuse of medicinal products;\n* Smoking more than 10 cigarettes per day currently, or a history of smoking the indicated number of cigarettes in the 6 months preceding screening; failure to agree to abstain from smoking for the duration of the hospital stay;\n* Consumption of alcohol, caffeine, and xanthine-containing products in the 7 days prior to taking the study drug;\n* Consumption of citrus fruits, cranberries, rose hips and products containing them, preparations or products containing St. John's wort - 7 days before taking the study drug;\n* Dehydration due to diarrhea, vomiting, or other cause within the last 24 hours prior to taking the study drug;\n* Positive blood test result for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens at screening;\n* Clinically significant abnormalities on electrocardiogram (ECG) in the medical history and\u002For at screening;\n* Positive urinalysis for narcotics and potent drugs at screening;\n* Positive breath alcohol vapor test at screening;\n* Scheduling a hospital stay during the study period, for any reason other than hospitalization required by this protocol;\n* Failure or inability to comply with protocol requirements, follow protocol procedures, diet and activity regimen.\n* Belonging to a vulnerable population, including: students enrolled in medical, pharmaceutical, or dental educational institutions, clinical and laboratory assistants, pharmaceutical company employees, military personnel and prisoners, persons residing in residential care facilities, low-income and unemployed, minorities, homeless, vagrants, refugees, persons in foster care, persons unable to consent, and law enforcement officers;\n* Any other condition that, in the judgement of the Investigator, would preclude the volunteer's enrollment in the study or could lead to premature withdrawal from the study, including adherence to fasting regimens or special diets (e.g., vegetarian, vegan, or sodium-restricted diets) or lifestyle factors (e.g., night-shift work or extreme physical exertion)\n\nExclusion criteria:\n\n* Voluntary withdrawal of the subject from the study;\n* Failure to comply with protocol requirements by the volunteer (e.g., missing scheduled study procedures, unauthorized use of prohibited medications, or violation of dietary or lifestyle restrictions);\n* Occurrence of any event or condition during the study that, in the investigator's judgement, may compromise the volunteer's safety (e.g., hypersensitivity reactions);\n* Volunteers selected for participation in the study in violation of the inclusion\u002Fnon-inclusion criteria;\n* Development of severe adverse event and\u002For a serious adverse event in a volunteer during the course of the study;\n* Volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;\n* Missing collection of 2 or more consecutive blood samples or 3 x or more blood samples during the same Study Period;\n* Occurrence of vomiting\u002Fdiarrhea within 6 h after administration of study drug;\n* Positive urine test for narcotics and potent drugs;\n* Positive breath alcohol test;\n* Positive pregnancy test in women;\n* Occurrence of any other circumstance that precludes conduct of the study in accordance with the protocol.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},45,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128 mg following both single and multiple oral dose administration.",[28,29],"Chronic Cholecystitis","Biliary Dyskinesia","RECRUITING","2026-06-10",{"date":33,"type":34},"2026-06-15","ACTUAL",{"date":36,"type":34},"2026-01-26",{"date":38,"type":22},"2027-06-30",{"name":40,"class":41},"Valenta Pharm JSC","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100637195","phase-3-efficacy-safety-and-tolerability-of-4-must-128-mg-tablets-in-chronic-cholecystitis-and-biliary-dyskinesia-100637195","NCT07595003","Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Chronic Cholecystitis and Biliary Dyskinesia","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","Inclusion Criteria:\n\n1. Males and females aged 18-70 years.\n2. Diagnosed with chronic cholecystitis (K81.1) and\u002For dyskinesia of the cystic duct or gallbladder (K82.8) prior to enrollment; diagnosis supported by clinical history of exacerbations and remissions and\u002For imaging\u002Flaboratory findings.\n3. 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.\n4. Maximum severity of pain\u002Fdiscomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).\n5. Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.\n6. The total bilirubin level does not exceed 2 times the upper limit of normal (no more than 42 μmol\u002FL).\n7. 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).\n8. Signed and dated informed consent from.\n\nNon-inclusion Criteria:\n\n1. Gastric or duodenal ulcer, erosive gastroesophageal reflux disease (GERD), or other inflammatory\u002Ferosive gastrointestinal diseases in the acute stage, unless stable remission for ≥ 1 year since the last exacerbation.\n2. Indication for surgical or endoscopic intervention due to exacerbation of chronic cholecystitis or complications of biliary tract dyskinesia.\n3. Toxic megacolon.\n4. Paralytic ileus.\n5. Gilbert's syndrome.\n6. Choledocholithiasis (or a high risk of its development, as determined by the investigator);\n7. Impaired bile outflow due to adhesions in the abdominal cavity.Abdominal adhesion disease.\n8. Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.\n9. Gastrointestinal malignancy (including history of) or suspected gastrointestinal malignancy (e.g., blood in stool, unexplained weight loss, fever, anemia).\n10. Any other oncological diseases known at the time of screening, or suspicion thereof.\n11. History of gastrointestinal surgery, including cholecystectomy or endoscopic sphincterotomy (appendectomy excluded).\n12. Use of prohibited therapy medications within 3 days prior to randomization.\n13. History of mental illnesses.\n14. Chronic heart failure IIb-III stages and\u002For III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.\n15. Chronic kidney disease stage IIIa-V (according to NKF\u002FKDOQI, 2006).\n16. 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.\n17. HIV, syphilis, viral hepatitis B or C, including in history.\n18. Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.\n19. Liver cirrhosis.\n20. Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.\n21. Severe, decompensated, or unstable somatic conditions that are life-threatening, worsen prognosis, or preclude safe study participation.\n22. Diabetes mellitus in a state of subcompensation and decompensation.\n23. Systemic connective tissue diseases.\n24. Autoimmune diseases.\n25. Indication for hemodialysis procedures.\n26. Epilepsy or seizures of unclear etiology, including in history.\n27. Alcoholism, substance abuse or drug addiction, including in history.\n28. Uncorrected electrolyte disturbances.\n29. QTcF interval on a 12-lead electrocardiogram (ECG) ≥430 ms in men and ≥450 ms in women.\n30. Episodes of constipation during the last 3 months that required the prescription of drug therapy.\n31. History of surgery within 6 month prior to screening.\n32. Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.\n33. Patients who require prohibited concomitant therapy within this study framework.\n34. Participation in another clinical trial within the last 3 months prior to the screening visit date.\n35. Unwillingness or inability to comply with study procedures and protocol requirements..\n36. Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.\n\nExclusion Criteria:\n\n1. Incorrect enrollment of a patient in the study (failure to meet inclusion\u002Fexclusion criteria at the time of randomization).\n2. 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\u002Fdiscomfort (assessed by Visual Analog Scale \\[VAS\\]) compared to baseline. Upon discontinuation, alternative therapy will be initiated at the investigator's discretion.\n3. Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).\n4. Requirement for prohibited concomitant therapy.\n5. Use of Duspatalin® (INN: mebeverine) for more than 3 consecutive days or for more than 5 days in total throughout the study.\n6. If the investigator judges that comtinued participation in the study would harm the patient.\n7. Pregnancy or the need for breastfeeding.\n8. Major protocol deviation by the subject with respect to procedures outlined in the Informed Consent Form (ICF).\n9. Withdrawal of informed consent by the subject (decision to discontinue study participation).\n10. Lost to follow-up: Inability to contact the subject after ≥3 documented attempts via mobile phone, landline (if applicable), and designated emergency contact.\n11. 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.\n12. Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.","70 Years",{"count":52,"type":22},300,[54],"PHASE3","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.",[28,29],"2026-05-12",{"date":59,"type":34},"2026-05-19",{"date":61,"type":34},"2025-12-12",{"date":63,"type":22},"2027-12-31",{"name":40,"class":41},10,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":42},"100625313","phase-1-pharmacokinetics-bioequivalence-and-safety-study-of-trimedat-7695-mg-orally-disintegrating-tablets-and-trimedat-100-mg-tablets-in-healthy-volunteers-100625313","NCT07421011","Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.","A Randomized, Open-label, Crossover Study to Assess the Comparative Pharmacokinetics, Bioequivalence, and Safety of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.","Inclusion Criteria:\n\n1. Voluntarily and personally signed informed consent form by a healthy volunteer obtained prior to the conduct of any study-related procedure;\n2. Males and females aged 18 to 45 years (inclusive) of Caucasian race.;\n3. Verified healthy status as demonstrated by the absence of clinically significant abnormalities in medical history, physical and instrumental examination, laboratory tests, and other diagnostic procedures specified in the protocol;\n4. Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mm Hg (inclusive);\n5. Heart rate (HR) from 60 to 89 beats per minute (inclusive);\n6. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive);\n7. Body temperature from 36.0°C to 36.9°C (inclusive);\n8. Body mass index (BMI) between 18.5 kg\u002Fm² and 30 kg\u002Fm², with a minimum body weight of ≥ 55 kg for men and ≥ 45 kg for women;\n9. Consent to use adequate contraceptive methods throughout the study and for 30 days after its completion, with a negative urine pregnancy test result for women of childbearing potential.\n\nNon-Inclusion Criteria:\n\n1. Clinically significant allergic history;\n2. Hypersensitivity to active and\u002For excipient substances in the investigational drug and comparator drug in the medical history;\n3. Drug intolerance to active and\u002For excipient substances in the investigational drug and comparator drug in the medical history;\n4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;\n5. Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, and immune systems, as well as skin, hematopoietic organs, and the eye;\n6. Surgical interventions on the GIT in the medical history (except for appendectomy performed at least 1 year prior to screening);\n7. Diseases\u002Fconditions that, in the investigator's judgment, may affect the absorption, distribution, metabolism, or excretion of the investigational drugs;\n8. Acute infectious diseases less than 4 weeks before screening;\n9. Use of drugs that significantly affect hemodynamics and drugs affecting liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening;\n10. Regular use of medications less than 2 weeks before screening and single use of medications less than 7 days before screening (including over-the-counter drugs, vitamins, dietary supplements, herbal medicines);\n11. Blood or plasma donating within 3 months prior to screening;\n12. Use of hormonal contraceptives (in women) within 2 months prior to screening;\n13. Use of depot injections of any medications within 3 months prior to screening;\n14. Pregnancy or lactation; positive urine pregnancy test result for women of childbearing potential;\n15. Female subjects of childbearing potential who had unprotected sexual intercourse with an unsterilized male partner within 30 days prior to administration investigational drugs;\n16. Participation in another clinical study within 3 months prior to screening or concurrently with this study;\n17. Consumption of more than 10 alcohol units per week (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of wine, or 50 ml of strong alcoholic beverages) in the last month before inclusion in the study or a history of alcoholism, drug addiction, or substance abuse;\n18. Smoking more than 10 cigarettes per day currently or smoking that amount in the past 6 months prior to screening; unwillingness to refrain from smoking during hospitalization;\n19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking investigational drugs;\n20. Consumption of citrus fruits, cranberries, rose hips and products containing them, or preparations\u002Fproducts containing St. John's wort within 7 days prior to taking investigational drugs;\n21. Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to taking investigational drugs;\n22. Positive blood test for antibodies to human immunodeficiency virus (HIV) types 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens during screening;\n23. ECG abnormalities in medical history and\u002For during screening;\n24. Positive urine test for narcotic substances and potent medications during screening;\n25. Positive breath alcohol test result during screening;\n26. Planning hospitalization during the study period for any reason other than hospitalization specified in the study protocol;\n27. Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, or adhere to dietary and activity restrictions;\n28. Membership in a vulnerable population, including but not limited to students of medical, pharmaceutical and dental educational institutions, junior staff of clinics and laboratories, employees of pharmaceutical companies, military personnel, prisoners, residents of care facillities, individuals with low income or unemployed, members of ethnic minorities, homeless persons, vagrants, refugees, individuals under guardianship or conservatorship, individuals unable to provide informed consent and law enforcement personnel;\n29. Other conditions that in the judgment of the Investigator may prevent volunteer inclusion in the study or lead to premature withdrawal from the study including adherence to fasting or special diets (e.g., vegetarianism, veganism, salt restriction) or special lifestyles (night work, extreme physical exertion).\n\nExclusion Criteria:\n\n1. Withdrawal of the volunteer from further participation in the study;\n2. Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);\n3. Emergence of reasons\u002Fsituations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);\n4. Volunteers selected for participation in the study who do not meet inclusion\u002Fexclusion criteria;\n5. Development of a severe and\u002For serios adverse event (AE\u002FSAE) in the volunteer during the study;\n6. The volunteer undergoes or requires treatment that may affect the pharmacokinetic parameters (PKP) of the investigational drugs;\n7. Missed collection of 2 or more consecutive blood samples or 3 or more blood samples within one study period;\n8. Occurrence of vomiting\u002Fdiarrhea within 6 hours after taking the investigational drug;\n9. Positive urine test for narcotic substances and potent medications;\n10. Positive breath test for alcohol vapors;\n11. Positive pregnancy test result in women;\n12. Emergence of other circumstances during the study that preclude conducting the study according to the protocol.",{"count":74,"type":22},36,[25],"This study aims to evaluate pharmacokinetic profile, safety and establish bioequivalence of the investigational drug Trimedat® 76,95 mg orally disintegrating tablets compared to the reference drug Trimedat® 100 mg tablets in healthy volunteers under fasted conditions.",[78,79,80,29,81],"Irritable Bowel Syndrome","Gallstone Disease","GERD","Postcholecystectomy Syndrome","2026-02-11",{"date":84,"type":34},"2026-02-19",{"date":86,"type":34},"2025-11-06",{"date":88,"type":22},"2026-12-31",{"name":40,"class":41},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":108,"locationsCount":109},"100580873","phase-2-efficacy-safety-and-tolerability-of-4-must-tablets-in-chronic-cholecystitis-and-biliary-dyskinesia-100580873","NCT06842966","Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia","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 Administered at Various Doses in Patients With Chronic Cholecystitis and Biliary Dyskinesia","Inclusion Criteria:\n\n1. Males and females aged 18-70 years.\n2. Presence of established gastrointestinal diseases: Chronic cholecystitis (K81.1); Dyskinesia of the bile duct or gallbladder (K82.8).\n3. Presence of pain\u002Fdiscomfort in the upper abdomen combined with at least one of the following symptoms: Heartburn; Belching; Nausea; Abdominal bloating; Borborygmi (stomach rumbling); Flatulence; Constipation; Diarrhea.\n4. Maximum severity of pain\u002Fdiscomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).\n5. Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.\n6. 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).\n7. Signed and dated informed consent from.\n\nNon-inclusion Criteria:\n\n1. Peptic ulcer disease, duodenal ulcer, erosive GERD.\n2. Toxic megacolon.\n3. Paralytic ileus.\n4. Gilbert's syndrome.\n5. Abdominal adhesion disease.\n6. Blood in stool, unexplained weight loss, fever, anemia.\n7. Inflammatory and erosive gastrointestinal diseases.\n8. Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.\n9. Oncological diseases of the gastrointestinal tract (including past diagnoses).\n10. History of gastrointestinal surgical procedures, including but not limited to endoscopic papillotomy and cholecystectomy, exept for appendectomy.\n11. Use of prohibited therapy medications within 3 days prior to randomization.\n12. History of mental illnesses.\n13. Chronic heart failure IIb-III stages and\u002For III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.\n14. Chronic kidney disease stage IIIa-V (according to NKF\u002FKDOQI, 2006).\n15. Established diagnosis of liver failure, including in history and\u002For changes in liver enzyme activity: Increase in AST, ALT, ALP and\u002For 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.\n16. HIV, syphilis, viral hepatitis B or C, including in history.\n17. Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.\n18. Liver cirrhosis.\n19. Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.\n20. 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).\n21. Diabetes mellitus in a state of subcompensation and decompensation.\n22. Systemic connective tissue diseases.\n23. Autoimmune diseases.\n24. Need for surgical and\u002For endovascular treatment and\u002For necessity for hemodialysis procedures.\n25. Epilepsy or seizures of unclear etiology, including in history.\n26. Alcoholism, substance abuse or drug addiction, including in history.\n27. Uncorrected electrolyte disturbances.\n28. History of surgery within 6 month prior to screening.\n29. Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.\n30. Patients who require prohibited concomitant therapy within this study framework.\n31. Participation in another clinical trial within the last 3 months prior to the screening visit date.\n32. Lack of willingness to cooperate from the patient's side.\n33. Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.\n\nExclusion Criteria:\n\n1. Incorrect enrollment of a patient in the study (failure to meet inclusion\u002Fexclusion criteria at the time of randomization).\n2. 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\u002Fdiscomfort 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.\n3. Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).\n4. Requirement for prohibited concomitant therapy.\n5. If the investigator judges that comtinued participation in the study would harm the patient.\n6. Pregnancy or the need for breastfeeding in the patient.\n7. Gross violation by the patient of the study protocol procedures outlined in the patient information sheet (PIS).\n8. Withdrawal of informed consent (patient's unwillingness to continue participation in the study).\n9. 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).\n10. 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.\n11. Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.",{"count":52,"type":22},[99],"PHASE2","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",[28,29],"2025-07-07",{"date":104,"type":34},"2025-07-11",{"date":106,"type":34},"2024-10-17",{"date":88,"type":22},{"name":40,"class":41},17]