Double-blind, Randomised, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Effect of Oral Ibodutant in Irritable Bowel Syndrome With Diarrhoea (IBS-D).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 565
- 试验地点
- 71
- 主要终点
- Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT).
研究概览
简要总结
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.
详细描述
The study evaluates the efficacy and safety of three doses of ibodutant, given once daily for 8 weeks versus placebo in IBS-D patients. Efficacy is evaluated in terms of overall symptom relief and abdominal pain/discomfort relief after 8 weeks of treatment. The clinical phase of the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind treatment period and a 2-week treatment withdrawal period, resulting in a 10-week overall duration of the study for each patient.
Patients report their IBS-related symptoms daily in an electronic diary (web-and telephone based)during all periods of the study.
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
- Triple (Participant, Care Provider, 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
- •At start of the run-in period:
- •Male or female patients aged 18 - 70 years with a clinical diagnosis of IBS-D according to the Rome III criteria:
- •Recurrent abdominal pain/discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics:
- •improvement with defecation;
- •onset associated with a change in the frequency of stool;
- •onset associated with a change in form (appearance) of stool.
- •Symptom-onset at least 6 months prior to diagnosis.
- •Loose/watery stools at least 25% of the time in the last 3 months AND hard/lumpy stools less than 25% of the time in the last 3 months.
- •More than 3 bowel movements per day at least 25% of the time in the last 3 months.
- •For patients older than 50 years OR patients with positive family history of colorectal cancer: Normal results from colonoscopy or flexible sigmoidoscopy.
- •Mentally competent, able to give written informed consent.
- •For women of childbearing potential: Use of a highly effective contraceptive method throughout the entire study period and up to 30 days post-treatment.
- •Normal physical examination or without clinically relevant abnormalities.
- •At randomisation:
- •Confirmation of IBS-D severity in terms of bowel movement frequency and abdominal pain intensity along the 2-week run-in period.
- •Exclusion criteria:
- •Organic abnormalities of the gastrointestinal tract, including history of colonic or major abdominal surgery.
- •History of gluten enteropathy.
- •Lactose intolerance as assessed by response to diet.
- •History of positive tests for ova or parasites, or occult blood in the stool.
- •Previous diagnosis of diabetes mellitus (either type 1 or 2).
- •Unstable medical condition.
- •Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease.
- •Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months.
- •Use of concurrent medication with drugs known to interfere with gastro-intestinal motility or sensitivity.
- •Pregnancy or breastfeeding.
排除标准
- 未提供
研究组 & 干预措施
Ibodutant low dose
Oral tablet, to be given once daily in fasting conditions.
干预措施: Ibodutant (Drug)
Ibodutant intermediate dose
Oral tablet, to be given once daily in fasting conditions.
干预措施: Ibodutant (Drug)
Ibodutant high dose
Oral tablet, to be given once daily in fasting conditions.
干预措施: Ibodutant (Drug)
Placebo
Oral tablet, to be given once daily in fasting conditions.
干预措施: Placebo (Drug)
结局指标
主要结局
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT).
时间窗: Eight weeks
Weekly binary questions (yes/no) from Interactive Voice/Web Response (IV/WRS) diary records: "Did you have satisfactory relief of your overall IBS symptoms during the last week?" and "Did you have satisfactory relief of your abdominal pain or discomfort during the last week?" Responder: Report of satisfactory overall IBS symptom relief ="Yes" and of satisfactory abdominal pain/discomfort relief = "Yes" 6/8 weeks (75% rule)
次要结局
- Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population(Eight weeks)
- Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)(Eight weeks)