NCT00457171终止1 期
A Double-Blind, Placebo-Controlled Phase I/II Study in Patients With Mild to Moderate Ulcerative Colitis Treated With GI-270384X, an Oral ICAM-1 and E-Selectin Inhibitor
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 主要终点
- Modified Truelove/Witts activity index for disease severity, between baseline and week 4 Endoscopic severity at 2 weeks Quality of life, as assessed by Inflammatory Bowel Disease Questionnaire, and changes on UC imaging scanning (leukocyte scan)
研究概览
简要总结
The aim of this double blind, placebo controlled, study is to evaluate activity consistent with efficacy provided by 14 days administration of GI270384X, and to provide preliminary pharmacokinetics and safety/tolerability of 14 days administration of GI270384X in patients with mild to moderate active ulcerative colitis (UC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females can be of childbearing or non-childbearing potential
- •Subjects who have relapsing (relapsed = 6 weeks ago; this being at least a second episode) mild to moderate UC (score of 4 - 11 on the MTWI at Screening and with an endoscopy score of = 2). Diagnosis of UC originally must be established by sigmoidoscopy or colonoscopy, and have compatible histology.
- •As confirmed through signed informed consent, the subject must understand and be able, willing and likely to fully comply with study procedures and restrictions
排除标准
- •Subjects with severe UC according to the MTWI (score >11) and subjects who have been in relapse for > 6 weeks.
- •Subjects are not eligible for this study if they have Crohn's Disease, proctitis (where the extent of inflammation = 15 cm), bleeding disorders, or active ulcer disease.
- •Positive stool culture for enteric pathogens (including Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas or Campylobacter).
- •Presence of Clostridium difficile toxin present or with ova or parasites as detected by microscopy.
结局指标
主要结局
Modified Truelove/Witts activity index for disease severity, between baseline and week 4 Endoscopic severity at 2 weeks Quality of life, as assessed by Inflammatory Bowel Disease Questionnaire, and changes on UC imaging scanning (leukocyte scan)
次要结局
- Vital signs (blood pressure, heart rate, body weight, 12-lead ECG), clinical laboratory data (haematology, clinical chemistry, urinalysis) and adverse events Cmax and AUC(0-4) of GI270384X, GI266193X and GW277348X after 14 days dosing.
研究者
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