EUCTR2004-000734-36-CZ进行中（未招募）1 期
A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.
Shire Pharmaceutical Development Inc.0 个研究点目标入组 125 人开始时间: 2004年10月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must sign the study 303 informed consent form, meet all eligibility requirements and have completed all assessments of the Study 301 or 302 End of Study /Early Withdrawal Visit.
- •Women of child bearing potential (WOP) must use an acceptable contraceptive method while the subject is on the study treatment.
- •Subject and investigator must egree that participation in the Acute and/or Maintenance Phase of this study is in the best interest of the subject
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject who have withdrawn from Study 301 or 302 before study visit 3, or subject who withdrew from Study 301 or 302 due to a possibly or probably related severe AE or SAE are not eligible to enter this study.
研究者
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