临床试验/NCT00545389

NCT00545389已完成2 期

A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily

Shire1 个研究点分布在 1 个国家目标入组 38 人开始时间: 2003年2月10日最近更新: 2021年6月11日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Shire
入组人数: 38
试验地点: 1
主要终点: % of subjects in remission (UC-DAI score)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).

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

•male & female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis
•general medical assessment satisfactory and no clinically significant and relevant abnormalities

排除标准

•severe ulcerative colitis
•subject in relapse for > 6 weeks
•use of systemic or rectal steroids within last 4 weeks prior to baseline
•subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease
•subjects hypersensitive to salicylates/aspirin
•subjects with moderate or severe renal impairment

结局指标

主要结局

% of subjects in remission (UC-DAI score)

时间窗: Week 8

次要结局

Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology(8 weeks)
Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA(8 weeks)
Safety and tolerability(8 weeks)

研究者

发起方

Shire

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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