NCT01207115已完成2 期
A Global Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Osteoarthritis Pain of the Knee
AbbVie (prior sponsor, Abbott)38 个研究点 分布在 5 个国家目标入组 322 人开始时间: 2010年9月最近更新:
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
- 入组人数
- 322
- 试验地点
- 38
- 主要终点
- 24-hour average pain score measured by Visual Analog Scale
研究概览
简要总结
To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) 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 (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 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
ABT-652 high dose
Experimental
ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm.
干预措施: ABT-652 (Drug)
ABT-652 low dose
Experimental
ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm
干预措施: ABT-652 (Drug)
Naproxen
Active Comparator
Naproxen capsules- twice daily for 8 weeks
干预措施: Naproxen (Drug)
Placebo
Placebo Comparator
Placebo capsules- twice daily for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
24-hour average pain score measured by Visual Analog Scale
时间窗: 8 weeks
Subject reported pain intensity measured by Visual Analog Scale (0-100)
次要结局
- SF-36v2™ Health Status Survey(8 weeks)
- Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores(8 weeks)
- Subject's Global Assessment of Arthritis Status(8 weeks)
- Brief Pain Inventory(8 weeks)
研究者
研究点 (38)
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