NCT01102660已完成2 期
A Randomized, Double-Blind, Double-Dummy, Placebo And Active Controlled Two Period Four Treatment Cross-Over Clinical Trial To Examine The Pain Relief Of PH-797804 Alone Or With Naproxen In Subjects With Flare-Enriched Osteoarthritis Of The Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Western Ontario & McMaster Osteoarthritis Index Pain Score
研究概览
简要总结
PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 subjects between, and including, the ages of 18 and 75 years. Females must be of non-childbearing potential.
- •Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2.
排除标准
- •History of diseases other than osteoarthritis that may involve the index knee.
- •Other severe pain that impairs the assessment of osteoarthritis of pain.
- •Electrocardiogram abnormalities.
- •History of gastrointestinal disorders.
研究组 & 干预措施
Treatment Sequence 3
Other
干预措施: Naproxen (Drug)
Treatment Sequence 1
Other
干预措施: PH-797804 (Drug)
Treatment Sequence 1
Other
干预措施: Placebo (Drug)
Treatment Sequence 2
Other
干预措施: Placebo (Drug)
Treatment Sequence 2
Other
干预措施: PH-797804 (Drug)
Treatment Sequence 3
Other
干预措施: Naproxen + PH-797804 (Drug)
Treatment Sequence 4
Other
干预措施: Naproxen + PH-797804 (Drug)
Treatment Sequence 4
Other
干预措施: Naproxen (Drug)
结局指标
主要结局
Western Ontario & McMaster Osteoarthritis Index Pain Score
时间窗: 2 weeks
次要结局
- Western Ontario & McMaster Osteoarthritis Index Total Score(2 weeks)
- Daily Pain Rating Scale(2 weeks)
- Western Ontario & McMaster Osteoarthritis Index Stiffness Score(2 weeks)
- Western Ontario & McMaster Osteoarthritis Index Physical Function Score(2 weeks)
研究者
研究点 (1)
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