A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 829
- 试验地点
- 140
- 主要终点
- Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months
研究概览
简要总结
Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.
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
- •previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days
- •female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception
排除标准
- •proctitis
- •previous resective colonic surgery
- •Crohn's disease
- •hypersensitivity to salicylates
- •moderate/severe renal impairment
研究组 & 干预措施
SPD476
Mesalazine
干预措施: SPD476 (Drug)
Asacol
干预措施: Asacol (Drug)
结局指标
主要结局
Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months
时间窗: 6 Months
Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal \[intact vascular pattern; no friability or granulation\], 1 = mild \[erythema; decreased vascular pattern; minimal granularity\], 2 = moderate \[marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations\], 3 = severe \[ulceration; spontaneous bleeding\].
次要结局
- Withdrawal Due to Relapse of UC(Over 6 Months)
- Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months(Baseline and 6 months)
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score(6 Months)
- Endoscopic Remission of UC With No or Mild Symptoms at 6 Months(6 Months)