EUCTR2007-003280-41-IT进行中（未招募）不适用
A randomised controlled multicenter trial assessing the efficacy and safety of mesalazine therapy in patients with irritable bowel syndrome. - ND
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
- SOFAR SPA
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
- •-IBS patients (both males and females) with positive diagnosis based on Rome III criteria. -18<=age<=56 years -negative outcome of barium enema or left colonoscopy within the previous five years -negative relevant additional screening or consultation whenever appropriate. -patients capable of conforming to the study protocol; -patients who have given their free and 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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-patients with ascertained inflammatory bowel diseases (Crohn's disease, diverticular disease, ulcerative colitis, infectious colitis, ischemic colitis, microscopic colitis, coeliac disease) -patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable) -presence of major abdominal surgeries -ascertained hypersensitivity to the salicylates -patients with history of clinically significant renal (creatinine >= 2.0 mg/dL or >=177 micromoli/L), hepatic (AST or ALT greater than three times the upper limit of normal range), cardiac, metabolic or haematological disease -esophageal, gastric or duodenal ulcer within 30 days prior to randomization -patients with intended or ascertained pregnancy; lactation -patients who become unable to conform to protocol -patients in topic or systemic antibiotic therapy during the last month -patients in current therapy with corticosteroids, immunosuppressant, lactoferrin, antiallergic compounds (e.g. mast cells stabilizers, antihistaminics) -treatment with any investigational drug within the previous 30 days -treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety -recent history or suspicion of alcohol abuse or drug addiction -any severe pathology that can interfere with the treatment or the clinical or strumental tests of the trial -previous participation in this study
研究者
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