NCT00833794已完成3 期
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,028
- 主要终点
- Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)
研究概览
简要总结
The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1 Tramadol Once A Day
Experimental
干预措施: Tramadol Once a day (Drug)
2 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)
时间窗: 12 weeks
The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.
次要结局
- Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)(week 12)
- Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment(6 weeks)
- Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)(12 weeks)
- WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)(12 weeks)
- WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)(12 weeks)
- Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)(12 weeks)
- Time to Response(12 weeks)
- Discontinuation Due to Lack of Efficacy(12 weeks)
- Discontinuation Due to Adverse Events(12 weeks)
研究者
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