NCT00317369终止2 期
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 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 to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral dose of 5-ASA and enteral nutrition in patients with active Crohn's disease.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active Crohn's disease
- •Patients who have a primary lesion in either the small intestine or the large intestine
- •Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
- •Patients who have either never received enteral nutrition or have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
- •Either inpatient or outpatient
排除标准
- •Patients who have an external fistula (including anal fistula) in which persistent drainage is observed (and who require treatment with antibiotics or synthetic antibacterial agents)
- •Patients with short bowel syndrome (and who require intravenous nutritional support due to insufficient intestinal nutrient uptake)
- •Patients with an artificial anus
- •Patients who have a complication of serious infectious disease (intra-abdominal abscess, etc.)
- •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: Week 8
Definition of clinical improvement: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI \< 150: Remission, CDAI \> 450: severe disease)
次要结局
- Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration(Week 2, Week 4，Week 8)
- Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration(Baseline, Weeks 2, 4, and 8)
- Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration(Week 2, Week 4)
- Mean Change in C-reactive Protein (CRP) Level From the Baseline 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, Week 8)
- Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration(Baseline, Weeks 2, 4, and 8)
- Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration(Baseline, Week 8)
研究者
研究点 (8)
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