NCT00259571撤回2 期
Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte ("Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- rate of relapses
研究概览
简要总结
The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis.
The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 15 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of ulcerative colitis in remission (CAI 3 or less)
- •signed letter of content
- •no steroids or immunosupressants in the last 6 weeks
- •at least 5 relapses in the last 3 years
- •last relapse was 8 months ago or less
- •complete colonoscopy at entry
排除标准
- •pregnancy or breast feeding
- •steroids or immunosuppressants
- •acute episode of UC
- •condition after complete or partial colektomy
- •known intolerance to mesalazin
- •severe medical disease other than colitis
结局指标
主要结局
rate of relapses
relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days
次要结局
- side effects
- time to the first relapse
- endoscopic index
- life quality
- amount of relapses per year
- histolgical score
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative ColitisPhosphatidylcholineUlcerative ColitisNCT00259545Heidelberg University60
已完成
2 期
Dose Finding Study for Retarded Phosphatidylcholine in PancolitisUlcerative ColitisNCT00259558Heidelberg University60
终止
3 期
A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)Ulcerative ColitisNCT02849951Prometheus Laboratories25
终止
3 期
Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative ColitisUlcerative ColitisNCT02142725Dr. Falk Pharma GmbH468
终止
不适用
A Study of the Efficacy of Subcutaneous Phosphatidylcholine and Deoxycholate Injections for Localized Fat RemovalObesityNCT00851747The Cleveland Clinic18
