EUCTR2008-000214-71-ES进行中（未招募）1 期
Estudio doble ciego, aleatorizado, controlado con placebo, de grupos paralelos para evaluar los efectos de un tratamiento de 4 semanas con dosis orales de MEN15596 en el síndrome de colon irritable.Double blind, randomized, placebo-controlled, parallel group study to evaluate the effect of a 4-week treatment with oral doses of MEN15596 in irritable bowel syndrome. - Not applicable
aboratorios Menarini S.A. (Menarini Group)0 个研究点目标入组 554 人开始时间: 2008年5月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 554
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
- •Patients meeting the following criteria will be eligible for entry into the study and start the run in period:
- •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
- •Patients meeting ANY of the following criteria will not be eligible to participate in the study:
- •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 antidepressants 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 of the Protocol.
- •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.
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