NCT01011322Unknown2 期
A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 156
- 试验地点
- 25
- 主要终点
- To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis
研究概览
简要总结
The participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. If the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1 telephone follow-up call.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 years or older who have given written Informed Consent
- •Patients with proven ulcerative colitis
- •Active disease course for the last 6 weeks or longer with bloody diarrhea
- •Patients with an inadequate response to a treatment with mesalazine or a documented intolerance to mesalazine.
排除标准
- •Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis,
- •Crohn's disease,
- •Colitis due to other reasons than ulcerative colitis like known diverticulitis, radiation colitis, ischemic colitis, microscopic colitis, or indeterminate colitis,
- •Treatment with other investigational medicinal product within 3 months prior to study entry
研究组 & 干预措施
LT-02 Dose 1
Experimental
0.2g IMP per dose
干预措施: LT-02 (Drug)
LT-02 Dose 2
Experimental
0.4g IMP per dose
干预措施: LT-02 (Drug)
LT-02 Dose 3
Experimental
0.8g IMP per dose
干预措施: LT-02 (Drug)
Sugar pill
Placebo Comparator
placebo matching to 0g of IMP,
干预措施: placebo (Drug)
结局指标
主要结局
To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis
时间窗: From day 1 of treatment until end of treatment
次要结局
- To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis(After study is completed)
研究者
研究点 (25)
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