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) - The Iris-2 Study. - IRIS-2

Menarini Ricerche S.p.A.0 个研究点目标入组 1,220 人2010年6月11日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Menarini Ricerche S.p.A.
入组人数: 1220
状态: 进行中（未招募）
最后更新: 13年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2010年6月11日

结束日期

待定

最后更新

13年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Menarini Ricerche S.p.A.

入排标准

入选标准

•Patients meeting the following criteria will be eligible for entry into the study and start the run\-in period:
•1\. Male or female patients aged 18 \- 70 years with a clinical diagnosis of IBS\-D according to the following symptom\-based criteria as per Rome III modular questionnaire criteria:
•\- Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.
•\- Symptom\-onset at least 6 months prior to diagnosis.
•\- Loose or watery stools at least 25% of the time in the last 3 months AND hard or lumpy stools less than 25% of the time in the last 3 months.
•\- Additional criterion: More than 3 bowel movements per day at least 25% of the time in the last 3 months.
•2\. For patients older than 50 years OR patients with positive family history of colorectal cancer: Normal results from colonoscopy or flexible sigmoidoscopy performed within the last 5 years and after the onset of IBS symptoms, and completed before Screening (Day \-14\).
•3\. Mentally competent, able to give written informed consent prior to study entry and compliant to undergo all visits and procedures scheduled in the study.
•4\. For women of childbearing potential: Use of a highly effective contraceptive method with a failure rate \<1% per year throughout the entire study period and up to 30 days post\-treatment. Oral contraceptives are allowed provided that they have not been changed in the previous 6 months.
•5\. Normal physical examination or without clinically relevant abnormalities.

排除标准

•Patients will not be eligible to participate in the study if they meet ANY of the following exclusion criteria:
•1\. Organic abnormalities of the GI tract, including history of colonic or major abdominal surgery, i.e. stomach, small/large bowel, or large vessel abdominal surgery (except appendicectomy, hysterectomy, cholecystectomy, caesarean section, or laparoscopic surgery), current or previous diagnosis of neoplasia (except non\-GI neoplasia in complete remission \= 5 years), inflammatory bowel diseases, symptomatic gallbladder stone disease, complicated diverticulosis (i.e. diverticulitis), ectopic endometriosis.
•NOTE: Patients with alarm signs (e.g. fever, rectal bleeding, unintentional weight loss, anaemia) deserve special consideration to exclude any organic GI disease.
•2\. History of gluten enteropathy.
•3\. Lactose intolerance as assessed by response to diet.
•4\. History of positive tests for ova or parasites, or occult blood in the stool in the previous 6 months.
•5\. Previous diagnosis of diabetes mellitus (either type 1 or 2\).
•6\. Unstable medical condition; i.e. patients for which concurrent diseases may compromise the efficacy and safety assessments as required in the study AND/OR require change in concomitant medication. NOTE: Thyroid hormone replacement therapy should be stable for at least the last 2 months.
•7\. Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease.
•8\. Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months.