EUCTR2008-000214-71-IT进行中（未招募）不适用
DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFECT OF A 4-WEEK TREATMENT WITH ORAL DOSES OF MEN15596 IN IRRITABLE BOWEL SYNDROME - ND
aboratorios Menarini S.A. - Menarini Group0 个研究点目标入组 560 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 560
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1-Mentally competent, able to give written informed consent prior to study entry and compliant to undergo all visits and procedures scheduled in the study.
- •2- Male or female patients aged 18 - 70 years.
- •3- Clinical diagnosis of IBS (all subtypes of IBS-d, IBS-c, IBS-m, or IBS-u) according to the following symptom-based criteria as per Rome III 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.
- •4.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 the start of run-in period (Day -14).
- •5.Use of appropriate contraceptive methods 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 six months.
- •6.Normal physical examination or without clinically relevant abnormalities.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.IBS patients having more than 3 bowel movements/day (for more than 1 day/ week) OR less than 2 bowel movements/week during the 2 week run in period.
- •2.Patients with organic abnormalities of the gastro-intestinal tract, including history of colonic or major abdominal surgery, (appendicectomy or hysterectomy excluded), current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
- •3.History of gluten enteropathy.
- •4.Lactose intolerance as assessed by response to diet.
- •5.Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
- •6.Previous diagnosis of Diabetes Mellitus (either type 1 or 2).
- •7.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 from at least two months.
- •8.Major psychiatric, neurological or cardiovascular disorders.
- •9.Use of prohibited concurrent medication within 7 days prior to screening, namely:
- •antimuscarinic drugs;
- •analgesic drugs (opioid or non-steroidal anti-inflammatory drugs): NOTE: short term use of paracetamol is allowed for max 2 consecutive days);
- •antidepressants. NOTE: the use of a single antidepressant is only allowed when the drug type and its dose regimen has not been changed in the previous six months;
- •benzodiazepines. NOTE: the use of a single benzodiazepine is only allowed when it is administered as sleep-inducer and the drug type and its dose regimen has not been changed in the previous six months;
- •other medications for IBS. NOTE: short-term use of the antidiarrhoeal Loperamid and laxative Bisacodyl 7 days prior to screening is allowed in accordance with the use described under section 7.3.1.
- •10.Pregnancy or breastfeeding.
- •11.Hypersensitivity to the drug excipients.
- •12.Patients not able to understand or collaborate throughout the study.
- •13.Participation in other clinical trials in the previous 4 weeks.
研究者
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