EUCTR2013-000891-13-DE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled multi-centre study to investigate the effectiveness and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitits
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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 with confirmed ulcerative colitis (UC) by symptoms, endoscopy and histology
- •- Patients with mild to moderate active ulcerative colitis (UC), i.e. CAI = 5 up to 10 points (including)
- •-Patients in whom the active UC is treated independent from any participation in the current study with oral mesalazine at least 14 days but not more than 28 days before Visit 2
- •-Age between 18 to 80 years (including)
- •-UC may reach from left-sided colitis to pancolitis
- •-Willing and able to understand and sign an approved Informed Consent form.
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •-Severe forms of UC (CAI > 10)
- •-Crohn’s disease, infectious colitis or undetermined colitis
- •-Steroid dependence and steroid resistance
- •-Concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants
- •-Topical mesalazin application
- •-Antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented
- •-Prior medication with biologicals, immune modifiers and immunosuppressants < 3 month wash-out
- •-Anticoagulant medication
- •-Any condition or concomitant therapy that in the opinion of the investigator may jeopardize the patients well-being
- •-Total colectomy
- •-Known allergies to components of STW5-II
- •-Severe allergic diathesis
- •-History of current or past alcohol or drug abuse
- •-Known intolerance to azo dyes E110 und E151
- •-Severe comorbidity
- •-Consumption of any investigational product within one month prior to the screening visit
研究者
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