NCT00088062已完成1 期
A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 35
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 18-65 years old
- •Crohn's Disease for 6 months
- •CDAI scores between 220-450
- •+/- 5-ASA, stable dose for > 2 weeks
- •+/- Corticosteroids, less than or equal to 40 mg per day with a stable dose for 2 weeks
- •+/- Infliximab with no treatment within 4 weeks
- •+/- 6-Mercaptopurine, with a stable dose for 8 weeks
- •+/- Antibiotics, with a stable dose for 2 weeks
排除标准
- •Patients who have had methotrexate, cyclosporine, or other experimental drug within 3 months of screening
- •Pregnancy, breast feeding
- •History of total proctocolectomy with stoma. Previous ileocolectomy would not be a contraindication to the study
- •Bowel obstruction
- •Surgical bowel resection within 90 days
- •Total parenteral nutrition (TPN), CYA, tacrolimus
研究者
研究点 (35)
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