NCT00379990已完成2 期
A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Measurment of synovial vascularity
研究概览
简要总结
This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the results from a previous study), prednisolone (7.5mg) or placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GW274150 60 mg once daily for 28 days
Experimental
60 mg GW274150 taken once daily for 28 days
干预措施: GW274150 (Drug)
Prednisolone 7.5 mg once daily for 28 days
Active Comparator
7.5 mg prednisolone taken once daily for 28 days
干预措施: Prednisolone (Drug)
Placebo once daily for 28 days
Placebo Comparator
Placebo taken once daily for 28 days
干预措施: Placebo (Other)
结局指标
主要结局
Measurment of synovial vascularity
时间窗: Day 1, Day 15 and Day 28
Power Doppler ultrasonographic measurement of synovial vascularity
次要结局
- Synovial thickness(Day 1, 15 and 28)
- Safety: ECG(Day 1, 15 and 28)
- Safety: Vital Signs(Day 1, 15 and 28)
- Safety: Laboratory(Day 1, 8, 15, 22, 28 and Follow Up)
- Pharmacokinetics: Cmax(Day 15 and Day 28)
- Pharmacokinetics: Trough(Days 8,15 and Day 28)
- Tolerability(Day 1 to Day 28 and Follow Up)
研究者
研究点 (1)
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