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

2026年5月12日 更新者：Valenta Pharm JSC

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

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

300

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 俄罗斯
      • Moscow、俄罗斯、119571
        • 招聘中
        • Unimed-C Jsc
        • 接触：
          • Olga Orlova, MD
          • 电话号码：+7 (919) 994-90-14
          • 邮箱：orlelik@mail.ru
      • Moscow、俄罗斯、117556
        • 招聘中
        • State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"
        • 接触：
      • Moscow、俄罗斯
        • 招聘中
        • The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
        • 接触：
      • Novosibirsk、俄罗斯
        • 招聘中
        • Limited Liability Company "ErSi Medical"
        • 接触：
      • Perm、俄罗斯、614990
        • 招聘中
        • Federal State Budgetary Educational Institution of Higher Education "Academician E.A. Wagner Perm State Medical University" of the Ministry of Healthcare of the Russian Federation
        • 接触：
      • Saint Petersburg、俄罗斯、194358
        • 招聘中
        • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
        • 接触：
      • Saint Petersburg、俄罗斯、196143
        • 招聘中
        • Limited Liability Company "Research Center Eco-Safety"
        • 接触：
      • Saint Petersburg、俄罗斯、196158
        • 招聘中
        • Limited Liability Company "Clinic Zvezdnaya"
        • 接触：
      • Saratov、俄罗斯、410071
        • 招聘中
        • State Healthcare Institution "Saratov City Clinical Hospital No. 5"
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：4-MUST
4-MUST: 384 mg (3 tablets), orally three times a day (TID), 30 min before meals. Total daily dose - 1152 mg.
药品：4-lust
128毫克的三铁丁氨酸4-甲基固体硫酸盐片。
其他名称：
  • Trimebutine 4-甲基固体硫酸盐
安慰剂比较：Placebo
Placebo: 3 tablets, orally three times a day (TID), 30 min before meals.
药品：安慰剂
安慰剂药片。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline
大体时间：Day 29 ± 1
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Day 29 ± 1

次要结果测量

结果测量
措施说明
大体时间
安全性和耐受性：生命体征 - 收缩压（SBP）
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
SBP，MMHG
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
安全性和耐受性：生命体征 - 舒张压（DBP）
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
DBP，MMHG
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
安全性和耐受性：生命体征 - 呼吸率（RR）
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
RR，每分钟呼吸
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
安全性和耐受性：生命体征 - 心率（HR）
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
人力资源，每分钟跳动
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
安全性和耐受性：生命体征 - 体温
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
体温，摄氏量表
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
体格检查结果：心血管系统
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
评估心血管系统的身体检查状况（正常情况或异常状况清单，如果有）
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
体格检查结果：消化道
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
评估在体格检查时消化道状况（正常情况或异常状况清单，如果有）
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
体格检查结果：内分泌系统
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
评估内分泌系统身体检查状况（正常情况或异常状况清单，如果有）
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
体格检查结果：肌肉骨骼系统
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
评估身体检查中肌肉骨骼系统的状况（正常情况或异常状况清单，如果有）
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
体格检查结果：神经系统
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
对身体检查中神经系统状况的评估（正常情况或异常状况列表，如果有）
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
体格检查结果：感觉系统
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
评估体格检查的感觉系统状况（正常情况或异常状况列表，如果有）
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
体格检查结果：皮肤/可见粘膜
大体时间：筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
评估皮肤/可见粘膜在体格检查中的状况（正常情况或异常状况清单，如果有）
筛选，第1天，第8±1，第15天±1，第22±1天，第29±1天
实验室和工具检查结果：临床血液检查 - 血红蛋白
大体时间：筛选，第15±1天，第29±1天
血红蛋白（g/l）
筛选，第15±1天，第29±1天
实验室和工具检查结果：临床血液检查 - 血细胞比容
大体时间：筛选，第15±1天，第29±1天
血细胞比容（％）
筛选，第15±1天，第29±1天
实验室和工具检查结果：临床血液测试 - 红细胞计数
大体时间：筛选，第15±1天，第29±1天
红细胞计数（细胞/L）
筛选，第15±1天，第29±1天
实验室和工具检查结果：临床血液测试 - 血小板计数
大体时间：筛选，第15±1天，第29±1天
血小板计数（细胞/L）
筛选，第15±1天，第29±1天
实验室和工具检查结果：临床血液测试 - 白细胞计数
大体时间：筛选，第15±1天，第29±1天
白细胞计数（细胞/L）
筛选，第15±1天，第29±1天
实验室和工具检查结果：临床血液测试 - 红细胞沉降率
大体时间：筛选，第15±1天，第29±1天
红细胞沉降率（mm/h）
筛选，第15±1天，第29±1天
实验室和仪器检查结果：临床血液检查 - 骨髓细胞
大体时间：筛选，第15±1天，第29±1天
白细胞配方奶粉（骨髓细胞，％）
筛选，第15±1天，第29±1天
实验室和工具检查结果：临床血液测试 - 带中性粒细胞
大体时间：筛选，第15±1天，第29±1天
白细胞配方（带中性粒细胞，％）
筛选，第15±1天，第29±1天
实验室和仪器检查结果：临床血液测试 - 分割的中性粒细胞
大体时间：筛选，第15±1天，第29±1天
白细胞配方（分段性嗜中性粒细胞，％）
筛选，第15±1天，第29±1天
实验室和仪器检查结果：临床血液检查 - 嗜酸性粒细胞
大体时间：筛选，第15±1天，第29±1天
白细胞配方（嗜酸性粒细胞，％）
筛选，第15±1天，第29±1天
实验室和工具检查结果：临床血液测试 - 嗜碱性粒细胞
大体时间：筛选，第15±1天，第29±1天
白细胞配方（嗜碱性粒细胞，％）
筛选，第15±1天，第29±1天
实验室和工具检查结果：临床血液测试 - 单核细胞
大体时间：筛选，第15±1天，第29±1天
白细胞配方（单核细胞，％）
筛选，第15±1天，第29±1天
实验室和仪器检查结果：临床血液检查 - 淋巴细胞
大体时间：筛选，第15±1天，第29±1天
白细胞配方（淋巴细胞，％）
筛选，第15±1天，第29±1天
实验室和工具检查结果：血液化学 - 葡萄糖
大体时间：筛选，第15±1天，第29±1天
葡萄糖浓度（mmol/L）
筛选，第15±1天，第29±1天
实验室和工具检查结果：血液化学 - 胆固醇
大体时间：筛选，第15±1天，第29±1天
总胆固醇浓度（mmol/L）
筛选，第15±1天，第29±1天
实验室和工具检查结果：血液化学 - 蛋白质
大体时间：筛选，第15±1天，第29±1天
总蛋白质浓度（g/L）
筛选，第15±1天，第29±1天
实验室和工具检查结果：血液化学 - 胆红素
大体时间：筛选，第15±1天，第29±1天
总胆红素浓度（Micromol/L）
筛选，第15±1天，第29±1天
实验室和工具检查结果：血液化学 - 肌酐
大体时间：筛选，第15±1天，第29±1天
肌酐浓度（Micromol/L）
筛选，第15±1天，第29±1天
实验室和工具检查结果：血液化学 - 碱性磷酸酶
大体时间：筛选，第15±1天，第29±1天
碱性磷酸酶活性（U/L）
筛选，第15±1天，第29±1天
实验室和仪器检查结果：血液化学 - 丙氨酸转氨酶
大体时间：筛选，第15±1天，第29±1天
丙氨酸转氨酶活性（U/L）
筛选，第15±1天，第29±1天
实验室和工具检查结果：血液化学 - 天冬氨酸跨激酶
大体时间：筛选，第15±1天，第29±1天
天冬氨酸转氨酶活性（U/L）
筛选，第15±1天，第29±1天
实验室和仪器检查结果：血液化学 - 伽玛GTP
大体时间：筛选，第15±1天，第29±1天
Γ-谷胱甘肽转肽酶活性（U/L）
筛选，第15±1天，第29±1天
实验室和仪器检查的结果：尿液分析 - 比重
大体时间：筛选，第15±1天，第29±1天
尿液的比重
筛选，第15±1天，第29±1天
实验室和工具检查结果：尿液分析 - pH
大体时间：筛选，第15±1天，第29±1天
尿液的pH
筛选，第15±1天，第29±1天
实验室和仪器检查结果：尿液分析 - 蛋白质
大体时间：筛选，第15±1天，第29±1天
蛋白质浓度（g/l）
筛选，第15±1天，第29±1天
实验室和工具检查的结果：尿液分析 - 葡萄糖
大体时间：筛选，第15±1天，第29±1天
葡萄糖浓度（mmol/L）
筛选，第15±1天，第29±1天
实验室和工具检查的结果：尿液分析 - 红细胞
大体时间：筛选，第15±1天，第29±1天
红细胞含量（视线数）
筛选，第15±1天，第29±1天
实验室和工具检查的结果：尿液分析 - 白细胞
大体时间：筛选，第15±1天，第29±1天
白细胞含量（视线数）
筛选，第15±1天，第29±1天
Mean reduction in the severity of pain/discomfort in the upper abdomen according to VAS by days 2-28 from the start of therapy
大体时间：Day 2 - Day 28
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Day 2 - Day 28
Frequency of response to therapy (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more) by days 8, 15, 22, and 29 following treatment initiation.
大体时间：Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Frequency of response to therapy (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more) by days 8, 15, 22, and 29 following treatment initiation.
大体时间：Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more)
大体时间：Day 29 ± 1
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Day 29 ± 1
Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more)
大体时间：Day 29 ± 1
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Day 29 ± 1
Frequency of clinical recovery (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS to 10 mm or less) by days 8, 15, 22, and 29 following treatment initiation.
大体时间：Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Time to clinical recovery (reduction in the severity of pain/discomfort in the upper abdomen according to VAS to 10 mm or less)
大体时间：Day 29 ± 1
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Day 29 ± 1
Change in the total score of gastroenterological symptom severity according to the GSRS questionnaire by days 8, 15, 22, and 29 following treatment initiation.
大体时间：Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Change in dyspeptic symptom severity, as assessed by the GSRS, expressed as score changes from baseline in the Abdominal Pain, Reflux, Indigestion, Diarrhea, and Constipation syndrome subscales at Days 8, 15, 22, and 29 following treatment initiation.
大体时间：Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Change in the severity of individual symptoms of dyspeptic disorders according to the GSRS questionnaire in points by days 8, 15, 22, and 29 following treatment initiation.
大体时间：Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Change in quality of life according to the total score on the SF-36 questionnaire by day 29 from treatment initiation.
大体时间：Day 29 ± 1
SF-36 (Short Form 36 Health Survey) is a self-reported questionnaire. It consists of 36 items that cover eight health domains: Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Bodily pain, General health perceptions, Vitality (energy and fatigue), Social functioning, Mental health. SF-36 produces a profile of scores for each domain, which can be summarized into two main components: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, where lower scores indicate greater disability and higher scores indicate better health.
Day 29 ± 1
Change in the total score on the PAGI-SYM questionnaire by days 15 and 29 from treatment initiation.
大体时间：Day 15 ± 1, and 29 ± 1
PAGI-SYM (Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index) is a patient-reported questionnaire designed to assess the severity of symptoms in upper gastrointestinal disorders (GERD, dyspepsia, and gastroparesis). It consists of 20 items grouped into six subscales: Heartburn/Regurgitation, Fullness/Early Satiety, Nausea/Vomiting, Bloating, Upper Abdominal Pain, and Lower Abdominal Pain. Each symptom is rated on a 6-point Likert scale from 0 (none) to 5 (very severe). The questionnaire provides a profile of scores for each subscale, as well as a total score. Higher scores indicate greater symptom severity.
Day 15 ± 1, and 29 ± 1
change in the total score on the Visceral Sensitivity Index questionnaire by days 15 and 29 from the start of therapy
大体时间：Day 15 ± 1, and 29 ± 1
VSI (Visceral Sensitivity Index) is a patient-reported questionnaire measuring gastrointestinal-specific anxiety (cognitive, affective, and behavioral responses to GI sensations). It consists of 15 items rated on a 6-point scale, producing a total score from 0 to 75. Higher scores indicate greater GI-specific anxiety. Originally validated in IBS patients, it is now used across various GI disorders.
Day 15 ± 1, and 29 ± 1
Change in the total score on the Emotional Distress - Depression - Short Form 4a questionnaire by days 8, 15, 22, and 29 from the start of therapy
大体时间：Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Emotional Distress - Depression - Short Form 4a (PROMIS Depression SF 4a) is a patient-reported questionnaire assessing depression symptoms over the past 7 days. It consists of 4 items rated on a 5-point scale. Raw scores (4-20) are converted to a standardized T-score (mean=50, SD=10). Higher scores indicate greater depression severity.
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Safety and Tolerability: adverse event (AE) rate
大体时间：From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Frequency of adverse events (AEs) or serious AEs (SAEs)
From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Safety and Tolerability: adverse event (AE) number
大体时间：From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Number of adverse events (AEs) or serious AEs (SAEs)
From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Safety and Tolerability: AEs associated with the study drug
大体时间：From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Number and frequency of AEs associated with the study drug
From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Safety and Tolerability: SAEs associated with the study drug
大体时间：From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Number and frequency of SAEs associated with the study drug
From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Safety and Tolerability: treatment discontinuation
大体时间：From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs
From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Physical examination results: respiratory system
大体时间：Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)
Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - CRP
大体时间：Screening, day 15 ± 1, day 29 ± 1
C-reactive protein, CRP (mg/L)
Screening, day 15 ± 1, day 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
大体时间：Screening, day 1, day 29 ± 1
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute)
Screening, day 1, day 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
大体时间：Screening, day 1, day 29 ± 1
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)
Screening, day 1, day 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
大体时间：Screening, day 1, day 29 ± 1
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)
Screening, day 1, day 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval
大体时间：Screening, day 1, day 29 ± 1
12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave) (Frederica correction)
Screening, day 1, day 29 ± 1

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月12日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年5月19日

上次提交的符合 QC 标准的更新

2026年5月12日

最后验证

2026年3月1日

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与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GIB-03-04-2025

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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