NCT00447486已完成2 期
A Multicentre, Randomised, Double-Blind, Placebo and Naproxen (500mg) BID Controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 Weeks in Adults With Osteoarthritis of the Knee
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 23
- 主要终点
- The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline
研究概览
简要总结
The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female outpatient, >= 40 years of age
- •meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
- •meets ARA functional status requirements
- •meets WOMAC pain subscale score requirements
- •has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days in each of the 4 weeks preceding screen
排除标准
- •any pre-specified clinical/biological/ECG abnormality
- •any pre-specified drug sensitivity
- •history of peptic ulceration or GI bleeding
- •use of protocol-specified medications
- •secondary cause of knee OA
- •lower extremity surgery within 6 months of screening
- •use of analgesics other than allowed per protocol
- •use of corticosteroids or hyaluronan outside of allowed window prior to screening
结局指标
主要结局
The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline
时间窗: 4 Weeks
次要结局
- WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments(4 Weeks)
研究者
研究点 (23)
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