NCT00317356终止2 期
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 8
- 主要终点
- Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration
研究概览
简要总结
The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active ulcerative colitis
- •Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
- •Either inpatient or outpatient
排除标准
- •Patients who have a history of intestinal resection (other than appendiceal resection)
- •Patients who have a complication of malignant tumor
- •Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period
结局指标
主要结局
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration
时间窗: Weeks 4 and 8
Definition of clinical improvement: Disease Activity Index (DAI) subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline
次要结局
- Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration(Baseline and Week 8)
- Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration(Weeks 4 and 8)
- Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration(Baseline, Weeks 4 and 8)
- Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration(Baseline and Week 8)
- Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration(Baseline, Weeks 4 and 8)
- Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration(Baseline, Weeks 2, 4 and 8)
- Clinical Improvement Rate After 4 Weeks of Study Drug Administration(Week 4)
研究者
研究点 (8)
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