NCT00449722已完成3 期
Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Rate of clinical remission
研究概览
简要总结
To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis
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
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm ab ano, confirmed by endoscopy and histology
- •Established or new diagnosis
- •Disease activity at baseline: Clinical Activity Index (CAI) >4 and Endoscopic Index (EI) >= 4
排除标准
- •Crohn's disease
- •Toxic megacolon
- •Present or past colorectal cancer
- •Symptomatic gastrointestinal disease
- •Serious secondary disease(s)
- •Baseline stool positive for germs causing bowel disease
- •Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline
- •Current relapse occurred under maintenance treatment with >2g/day mesalazine
- •Serum creatinine >= 1.2x upper limit of normal (ULN) and creatinine clearance < 60 ml/min per 1.73 m2
- •Serum transaminase (ALT and/or AST), and/or alkaline phosphatase >= 2x ULN
结局指标
主要结局
Rate of clinical remission
次要结局
- Rate of clinical response
- PGA
- rate of endoscopical remission
- rate of endoscopical response
- rate of histological remission
- rate of histological response
- time to resolution of symptoms
研究者
研究点 (1)
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