NCT00808977已完成2 期
A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis
Palau Pharma S.L.U.22 个研究点 分布在 4 个国家目标入组 80 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 22
- 主要终点
- Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal
研究概览
简要总结
The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 inclusive
- •Male, non-child-bearing female or fertile female with appropriate contraception.
- •Mild to moderate confirmed active ulcerative colitis
- •Able and willing to give informed consent
排除标准
- •Colitis of other cause
- •Pregnancy, inadequate contraception for fertile female patients
- •Liver or kidney disease, unstable cardiovascular disease, coagulation disorder.
- •Other significant medical condition that preclude participation at investigator criteria
- •Allergy or hypersensitivity to salicylates
- •Previous or concomitant treatment for ulcerative colitis interfering with safety or activity assessments
研究组 & 干预措施
Dersalazine
Experimental
干预措施: Dersalazine sodium (Drug)
Mesalazine
Active Comparator
干预措施: Mesalazine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal
时间窗: 7, 14, 21, 28, 56 days
次要结局
- Mayo index(28 days)
研究者
研究点 (22)
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