Comparative Efficacy and Safety of Fenoverine and Trimebutine Maleate in Irritable Bowel Syndrome; A Randomized Double-blind Parallel Multi-center Phase IV Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 7
- 主要终点
- the proportion of subjects with improvement in abdominal pain or discomfort
研究概览
简要总结
It is a randomized double-blind parallel phase IV study to compare Fenoverine and Trimebutine maleate in the efficacy and safety.
Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and safety.
详细描述
For subjects with IBS, Fenoverine and Trimebutine will be administered orally for 8 weeks; Fenoverine 100mg capsule three times a day and Trimebutine 150mg tablet three times a day. Because one is capsule and the other is tablet, double dummy design will be used. Efficacy is evaluated at the end of 8 weeks and safety will be followed for 4 more weeks after the end of the scheduled medication.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older and 60 years of age or younger
- •Diagnosed as irritable bowel syndrome using Rome III Criteria
- •Female subjects of child-bearing potential are confirmed to have a negative urine beta-hCG test within 7 days prior to administration of initial dose of investigational products.
- •Female subjects of child-bearing potential must agree to use contraceptive measures during study period.
排除标准
- •Known allergy or hypersensitivity to investigational products or components of the formulation
- •Past or current diagnosis of chronic liver disease (e.g., liver cirrhosis, acute hepatitis, alcoholic hepatitis, chronic alcohol abuse and HCC)
- •Past or current diagnosis of Myopathy
- •Subject with serious renal disease
- •Known medical condition assessed by investigators as inappropriate for the study
- •Continuous use of NSAIDS, analgesics, steroids, or other immunosuppressants.
- •Continuous use of HMG-CoA reductase inhibitors or fibrates to lower blood lipid level
- •Pregnant, lactating, or planning to be pregnant women
- •Evidence of abuse of drugs or alcohol within 6 months prior to screening
- •Participation in other clinical trials within 3 months prior to enrollment or elapse of less than 5 half lives of previous investigational product after last dose of it.
- •Unable to submit informed consent or comply with the requirements of the study
研究组 & 干预措施
Fenoverine
Fenoverine 100mg three times a day will be administered for 8 weeks.
干预措施: Fenoverine (Drug)
Trimebutine
Trimebutine maleate 150mg three times a day will be administered for 8 weeks.
干预措施: Timebutine (Drug)
结局指标
主要结局
the proportion of subjects with improvement in abdominal pain or discomfort
时间窗: week 8
the proportion of subjects who experienced more than 30% improvement in abdominal pain or discomfort score with visual analog scale at week 8 compared to baseline
次要结局
- BSS scores (each and total)(week 4, 8)
- overall BSS score(Week 4, 8)
- subject's satisfaction with treatment(week 4, 8)
- adverse event(at each visit or contact until 4 weeks after the last dose)