EUCTR2007-000060-25-HU进行中（未招募）不适用
Efficacy and Safety of Meteospasmyl in Irritable Bowel Syndrome. a 4-week, multicentre, double-blind, randomised, placebo-controlled phase IV trial
aboratoires Mayoly Spindler SA0 个研究点目标入组 400 人开始时间: 2007年2月26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
- 400
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
- •For inclusion into the run-in period:
- •male or female ambulatory patients, aged 18-75 years
- •with IBS as defined by Rome III criteria: recurrent abdominal pain/discomfort at least 3 days per month in the 3 last months, with onset at least 6 months previously, associated with 2 or more of the following:
- •improvement with defecation
- •onset associated with a change in frequency of stool
- •onset associated with a change in form of stool
- •with a disease history < 5 years
- •able to adequately express IBS symptom complaints
- •able and willing to comply with study visits and procedures per protocol
- •having given a written informed consent
- •for women of childbearing potential, with adequate contraception
- •For randomisation into the study:
- •Pain/discomfort frequency of at least 2 days a week during each of the 2 weeks of run-in period
- •Intensity of their pain /discomfort = 60 mm on VAS at randomisation
- •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
- •Functional bowel disorder other than IBS (FAPS, isolated constipation)
- •Clinical alert signs such as anaemia, rectorrhagia, unexplained weight loss, general health status deterioration
- •Underlying cause for symptomatology, which excludes IBS diagnosis (diabetes, thyroid dysfunction, bilio-pancreatic disorders, infectious diarrhoea…)
- •Gastro-intestinal cancer or significant gastro-intestinal surgical background
- •Any acute/uncontrolled systemic pathology
- •Liver function tests = 3 times the upper normal limit
- •Known intolerance to Meteospasmyl® or one of its components
- •Regular use of Meteospasmyl within 6 months prior to inclusion
- •Use of antispasmodic, anti-diarrhoeal or laxatives; they must be stopped at inclusion, before entering the run-in period
- •Regular use of products able to interfere with study product evaluation. Anti-depressants must be taken at fixed dosage since three months prior to inclusion, anxiolytics must be taken at fixed dosage since one month prior to inclusion
- •Pregnant or breast-feeding women
- •Women of child-bearing potential without effective contraception (oral pill or intra-uterine device); if necessary a pregnancy test may be performed before entering the study
- •Patients likely to be non-compliant
- •Patients who have already been included in this study or who are participating in another study
- •Patients having received any other investigational agent within 3 months before randomisation
- •Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
研究者
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