EUCTR2004-001677-26-HU进行中（未招募）1 期
olpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE
Sanofi-Synthelabo Recherche0 个研究点目标入组 300 人开始时间: 2004年11月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •Male or female patients of at least 18 years old, with Ulcerative Colitis, of at least 6 months duration, that are 5-aminosalicylic acid or sulphasalazine resistant defined as a Disease Activity Index of the Mayo Score included in [6-10], despite a 4 weeks treatment of 5-ASA or sulphasalazine (at least 2 g/day).
- •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
- •- Pregnant or breastfeeding women.
- •- Chrön disease.
- •- Positive stool cultures.
- •- Treatment with methotrexate or cyclosporine or corticosteroïds over 20 mg/day of prednisolone.
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