NCT07595003招募中3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 9
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-70 years.
- •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.
- •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.
- •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.
- •The total bilirubin level does not exceed 2 times the upper limit of normal (no more than 42 μmol/L).
- •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:
- •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.
- •Indication for surgical or endoscopic intervention due to exacerbation of chronic cholecystitis or complications of biliary tract dyskinesia.
- •Toxic megacolon.
- •Paralytic ileus.
- •Gilbert's syndrome.
- •Choledocholithiasis (or a high risk of its development, as determined by the investigator);
- •Impaired bile outflow due to adhesions in the abdominal cavity.Abdominal adhesion disease.
- •Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
- •Gastrointestinal malignancy (including history of) or suspected gastrointestinal malignancy (e.g., blood in stool, unexplained weight loss, fever, anemia).
- •Any other oncological diseases known at the time of screening, or suspicion thereof.
- •History of gastrointestinal surgery, including cholecystectomy or endoscopic sphincterotomy (appendectomy excluded).
- •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).
- •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.
- •HIV, syphilis, viral hepatitis B or C, including in history.
- •Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.
- •Liver cirrhosis.
- •Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.
- •Severe, decompensated, or unstable somatic conditions that are life-threatening, worsen prognosis, or preclude safe study participation.
- •Diabetes mellitus in a state of subcompensation and decompensation.
- •Systemic connective tissue diseases.
- •Autoimmune diseases.
- •Indication for hemodialysis procedures.
- •Epilepsy or seizures of unclear etiology, including in history.
- •Alcoholism, substance abuse or drug addiction, including in history.
- •Uncorrected electrolyte disturbances.
- •QTcF interval on a 12-lead electrocardiogram (ECG) ≥430 ms in men and ≥450 ms in women.
- •Episodes of constipation during the last 3 months that required the prescription of drug therapy.
- •History of surgery within 6 month prior to screening.
- •Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.
- •Patients who require prohibited concomitant therapy within this study framework.
- •Participation in another clinical trial within the last 3 months prior to the screening visit date.
- •Unwillingness or inability to comply with study procedures and protocol requirements..
- •Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.
排除标准
- •Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
- •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.
- •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.
- •Use of Duspatalin® (INN: mebeverine) for more than 3 consecutive days or for more than 5 days in total throughout the study.
- •If the investigator judges that comtinued participation in the study would harm the patient.
- •Pregnancy or the need for breastfeeding.
- •Major protocol deviation by the subject with respect to procedures outlined in the Informed Consent Form (ICF).
- •Withdrawal of informed consent by the subject (decision to discontinue study participation).
- •Lost to follow-up: Inability to contact the subject after ≥3 documented attempts via mobile phone, landline (if applicable), and designated emergency contact.
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo: 3 tablets, orally three times a day (TID), 30 min before meals.
干预措施: Placebo (Drug)
4-MUST
Experimental
4-MUST: 384 mg (3 tablets), orally three times a day (TID), 30 min before meals. Total daily dose - 1152 mg.
干预措施: 4-MUST (Drug)
研究者
研究点 (9)
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