EUCTR2011-003418-18-SE进行中（未招募）不适用
A Randomised, Double Blind, Placebo Controlled, Multi-centre, Parallel Group, Interventional Study of Mesalazine (Asacol®) Treatment in IBS and the Evaluation of Rectal Inflammatory Status using the Mucosal Patch Technique - The MIBS Study
Sahlgrenska University Hospital0 个研究点目标入组 200 人开始时间: 2011年12月5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
- 200
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) Males and females aged 18 to 70 years, both inclusive
- •2) Subject is diagnosed with irritable bowel syndrome (IBS) prior to Screening based on the Rome III diagnostic criteria for IBS
- •3) Subject presents with IBS symptom intensity of at least moderate level; defined as an IBS Severity Scoring System (IBS-SSS) score of =175 at both Screening and Baseline
- •4) Provision of signed informed consent
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1) Subjects who are unable to understand the written and verbal instructions
- •2) Presence of a systemic inflammatory disease
- •3) Presence of other gastrointestinal diseases likely to explain the IBS symptoms
- •4) Presence of other severe somatic disease
- •5) Treatment with non-steroidal anti-inflammatory drugs (NSAID), opioid analgetics or acetylsalicylic acid (ASA) compounds within 7 days prior to Screening
- •6) Treatment with systemic antibiotics within 28 days prior to Screening
- •7) Treatment with immunosuppressant drugs within 28 days prior to Screening
- •8) Other significant medical treatment, which, in the opinion of the investigator, may compromise the safety and efficacy objectives of the study, within 28 days prior to Screening
- •9) Previously confirmed allergy towards ASA or mesalazine
- •10) Presence of renal disease and/or concomitant treatment with medications with potential renal side effects
- •11) Current ongoing infection
- •11) History of, or current, drug or alcohol dependence
- •12) Pregnant or lactating women
- •13) Subjects suspected not to follow instructions based on the discretion of the Investigator
- •14) Current participation in other intervention studies
- •15) Female subjects of childbearing potential unwilling to use adequate contraceptive measures throughout the duration of the study.
研究者
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