NCT00483977终止2 期
A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicentre Study To Assess The Efficacy And Tolerability Of PF-00592379 In Patients With Moderate To Severe Pain Due To Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Change from baseline in the pain score averaged over the last week of treatment
研究概览
简要总结
The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any race
- •Between the ages of 18 and 75 years
- •Knee Pain due to osteoarthritis
排除标准
- •Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline
- •History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year
研究组 & 干预措施
Oxycodone
Active Comparator
干预措施: Oxycodone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
PF-00592379
Experimental
干预措施: PF-000592379 (Drug)
结局指标
主要结局
Change from baseline in the pain score averaged over the last week of treatment
时间窗: 2 weeks
次要结局
- Pharmacokinetic trough levels(2 weeks)
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment(2 weeks)
- Patient Global Impression of Change(2 weeks)
- Patients Global Assessment of Osteoarthritis(2 weeks)
研究者
研究点 (1)
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