A Randomized, Placebo-Controlled Single-Dose 3-Period Crossover Study to Assess the Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks
研究概览
简要总结
The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The primary source of pain is the study knee of one lower extremity
- •Patient is willing to limit alcohol and caffeine intake
- •Aside from osteoarthritis, patient is in generally good health
- •Patient is capable of completing protocol specified walks
- •Patient is able to understand and complete questionnaires in English
- •Patient has previously benefited from the use of either NSAIDs, COX-2 inhibitors, or acetaminophen
排除标准
- •Patient has another condition which could interfere with evaluating pain in the knee being tested
- •Patient is not able to take a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen
- •Patient has a history or current evidence of stroke, transient ischemic attack, liver disease or cancer
- •Patient has a history or current evidence of dizziness, unsteadiness, or falling
- •Patient has congestive heart failure, unstable angina or uncontrolled high blood pressure
- •Patient has a history of stomach, digestive track, or small intestine surgery
- •Patient is unable to complete the study questionnaires in English
研究组 & 干预措施
1
Ibuprofen
干预措施: ibuprofen (Drug)
2
Placebo 1
干预措施: Placebo (Drug)
3
Placebo 2
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks
时间窗: All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)
Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk. Change from baseline was average of post-dose PIs minus average of pre-dose PI.
次要结局
未报告次要终点