NCT00372801已完成1 期
A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Pilot Study to Investigate the Efficacy of Ibuprofen in Patients With Osteoarthritis of the Knee Following Administration of a Single Dose
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale).
研究概览
简要总结
To demonstrate that new drugs work, many complex multidose studies are often required. The intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to validate a simpler single dose model for future assessment of new pain drugs.
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
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with primary Osteoarthritis of the knee.
- •Have at least 3 months in symptom duration prior to screening visit.
- •Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
- •Pain walking on flat surface within specific interval prior to study start.
排除标准
- •History of hypersensitivity to NSAIDS.
- •Allergy to Ibuprofen.
- •Use of assistive devices other than a cane or knee brace.
- •History of specified diseases/illnesses.
- •Abnormal blood tests pre-study.
结局指标
主要结局
Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale).
次要结局
- Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol)
研究者
研究点 (2)
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