NCT00101946已完成2 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Nine-weeks Administration of Three Doses of SB-683699 in Subjects With Moderately to Severely Active Crohn's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 20
- 主要终点
- Proportion of subjects who are responders at Week 6.
研究概览
简要总结
This study will evaluate the effectiveness and safety of the investigational drug 683699 in treating subjects with moderately to severely active CD (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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with CD and reconfirmed in previous 2 years by a radiologic or endoscopic assessment including histology.
- •CDAI (Crohn's Disease Activity Index) score of 220-450 after 1 week of screening.
- •CRP (C-Reactive Protein) level of >4mg at screening.
排除标准
- •Significantly abnormal laboratory tests or ECG (electrocardiogram) results.
- •Current use of an elemental diet or parenteral nutrition.
- •Clinically significant positive stool culture.
- •Ongoing neoplastic disease of the bowel.
- •Bowel perforation other than fistulae.
- •Has an ileostomy or colostomy.
- •Fixed symptomatic gastrointestinal (GI) stricture within 6 months or obstructive symptoms within 3 months of screening.
- •Any bowel resection within 12 months of screening or bowel resection without subsequent demonstration of recurrence of active CD.
- •More than 100cm of bowel resected.
- •Non-curative bowel surgery with 2 months of screening.
- •Symptoms attributed to short bowel syndrome.
- •Uncontrolled bacterial, viral, or fungal infection or congenital or acquired immunodeficiency.
- •Women who are pregnant, breast feeding, or planning to become pregnant during the study.
- •Permitted medications:
- •Less than or equal to 20mg/day oral corticosteroids for at least 4 weeks prior to screening and on stable doses for 2 weeks prior to screening.
- •Azathioprine and 6-MP (6-Mercaptopurine) stable dose for 3 months prior to screening.
- •5-ASA (5-Aminosalicylic acid) stable dose for 1 month prior to screening.
- •Prohibited medications:
- •Greater than 20mg/day oral corticosteroids, or systemic intravenous corticosteroids, or antibiotics as a treatment for CD within 4 weeks prior to screening.
- •Cyclosporine or methotrexate during the 2 months prior to screening.
- •Infliximab or other biological treatments within 3 months prior to screening.
结局指标
主要结局
Proportion of subjects who are responders at Week 6.
次要结局
- - Proportion of subjects with response at other timepoints. - Proportion of subjects in remission. - Average rate of response for the CDAI score. - Mean change from baseline in CDAI score Improvement in Quality of Life.
研究者
研究点 (20)
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