EUCTR2005-001655-38-BE进行中（未招募）不适用
Otilonium Bromide in Irritable Bowel Syndrome – (OBIS)Double blind, randomized, parallel group, placebo-controlled study to evaluate the effect of otilonium bromide on abdominal pain and quality of life in patients with irritable bowel syndrome Barostat sub-study:Effect of otilonium bromide versus placebo on the perception of rectal distension in patients with irritable bowel syndrome (IBS).
Menarini IFR – International Division0 个研究点目标入组 336 人开始时间: 2005年11月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 336
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
- •? Positive diagnosis for IBS according to the following symptom-based criteria (Rome II):
- •12 weeks or more, which need not to be consecutive, in the last 12 months of abdominal pain/discomfort that has two of the following three features:
- •(a) Relieved by defecation
- •(b) Associated with a change in frequency of stool
- •(c) Associated with a change in consistency of stool
- •? At least 2 episodes of abdominal pain for each week during the two weeks of run-in (at visit 2).
- •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
- •? Pregnant and breast-feeding women
- •? Simultaneous participation in another clinical trial
- •? Inability to maintain the conditions of the trial
- •? Severe psychiatric disorders
- •? Severe neurological disorders
- •? Severe heart failure, severe ischemic heart disease and severe hypertension
- •? Lactose intolerance
- •? Any clinical condition capable of causing gastrointestinal malabsorption
- •? Previous intestinal surgery except appendicectomy
- •? History of organic gastro-intestinal disease, (e.g. inflammatory bowel disease, cancer, ectopic endometriosis)
- •? Parasitosis infection
- •? Bowel obstruction
- •? History of the following diseases in the previous 4 months:
- •? Clinically symptomatic severe anaemia
- •? Cholestasis
- •? Diabetes mellitus requiring treatment with oral antidiabetics or insulin
- •? Severe hepatic or renal functional abnormality according to investigator’s opinion
- •? Any chronic use (> 2 weeks continuously) in the previous month of concomitant medication that may affect gastro-intestinal motility and function and that cannot be stopped during the trial such as: anticholinergics, prokinetics, laxatives, antidiarrhoeals, analgesics, NSAIDs, opiates, antidepressants, probiotics and drugs adjusting the microbial state. An antithrombotic treatment with low dose of aspirin is permitted.
- •? Clinically relevant abnormal values in the laboratory tests
- •? Prostatic hypertrophy
- •? Pyloric stenosis
- •? Hypersensitivity to any ingredient of the study products (otilonium bromide and/or excipients).
研究者
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