NCT00151944已完成3 期
A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 400
- 主要终点
- Treatment emergent adverse events
研究概览
简要总结
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis 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
- None
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
- •Subjects must have completed all assessments of SPD476-301 or SPD476-302 End of Study/Early Withdrawal Visit
- •Subjects who did not achieve remission at the End of Study/Early Withdrawal Visits in Study 301 or 302 will be eligible to enter the Acute Phase; subjects who did achieve remission at the End of Study Visits in Study 301 or 302 will be eligible to enter directly into the Maintenance Phase
- •Women of childbearing potential must use an acceptable contraceptive method while on study treatment
排除标准
- •Subjects who withdrew from Study 301 or 302 before Study Visit 3, or who withdrew due to a possible or probably related severe adverse event or serious adverse event are not eligible to enter this study
结局指标
主要结局
Treatment emergent adverse events
时间窗: Throughout the study period of approximately 2 year, 4 months
次要结局
- Participant compliance(Up to 12-14 months)
- Patient questionnaire(Month 6, and Month 12)
- Time to relapse(Up to 12-14 months)
- Number of participants in remission(12 months)
- Ulcerative colitis disease activity index (UC-DAI) score(Baseline, Month 2, and Month 12)
研究者
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