Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Effect of a 4-week Treatment With Oral Doses of Ibodutant (Code: MEN15596) in Irritable Bowel Syndrome (IBS).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 554
- 试验地点
- 6
- 主要终点
- Response of Overall IBS Symptom Relief - 50% Rule
研究概览
简要总结
The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.
详细描述
Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. This trial aims to evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral administration, testing three dosages or placebo in IBS patients for 4-weeks. In each patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal period, for total study duration of 8 weeks in each patient.
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
- •Male or female patients aged 18 - 70 years.
- •Clinical diagnosis of IBS .
- •For patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy.
- •Use of appropriate contraceptive methods.
- •Normal physical examination or without clinically relevant abnormalities.
排除标准
- •Patients with organic abnormalities of the gastro-intestinal tract including history of colonic or major abdominal surgery, current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
- •History of gluten enteropathy.
- •Lactose intolerance as assessed by response to diet
- •Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
- •Previous diagnosis of Diabetes Mellitus (either type 1 or 2)
- •Unstable medical condition.
- •Concomitant medication within 7 days prior to screening with drugs known to interfere with gastro-intestinal motility and sensitivity.
- •Pregnancy or breastfeeding.
- •Patient not able to understand or collaborate throughout the study.
- •Participation in other clinical trials in the previous 4 weeks.
研究组 & 干预措施
Ibodutant 10 mg
干预措施: Ibodutant (Drug)
Ibodutant 30 mg
干预措施: Ibodutant (Drug)
Ibodutant 60 mg
干预措施: Ibodutant (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Response of Overall IBS Symptom Relief - 50% Rule
时间窗: Four weeks
Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?" Responder: report of satisfactory overall IBS symptom relief = "Yes" 2/4 weeks (50% rule)
次要结局
- Response of Overall IBS Symptom Relief - 75% Rule(Four weeks)
- Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule(Four weeks)