NCT01444365已完成2 期
A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of ABT-652 as an Add On Therapy in Subjects With Osteoarthritis of the Knee Experiencing Partial Benefit of a Nonsteroidal Anti-Inflammatory Drug
AbbVie (prior sponsor, Abbott)31 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2011年10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
- 202
- 试验地点
- 31
- 主要终点
- Subject's Assessment of Arthritis Pain Intensity
研究概览
简要总结
To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of the knee.
详细描述
This is a randomized withdrawal design study, containing a 4 week open-label period followed by a 6 week double-blind period. The total treatment period will be 10 weeks.
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
- Triple (Participant, Care Provider, 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
- •History of osteoarthritis (OA) of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria,
- •Currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and still experiencing pain as per the protocol requirements.
- •Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.
排除标准
- •Diagnosis of rheumatoid arthritis, autoimmune disorder, arthritis other than osteoarthritis involving the study joint, or other painful syndrome that could interfere with the assessment of pain at the study joint
- •Any cardiac, respiratory, neurological, psychiatric disorder or any other medical condition or illness that is not well controlled with treatment
研究组 & 干预措施
ABT-652 NSAID
Experimental
ABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed
干预措施: ABT-652 NSAID (Drug)
Placebo NSAID
Placebo Comparator
Placebo - 2 placebo capsules twice daily NSAID - as prescribed
干预措施: Placebo NSAID (Drug)
结局指标
主要结局
Subject's Assessment of Arthritis Pain Intensity
时间窗: 6 weeks
Subject reported 24-hour average pain score measured by Visual Analogue Scale
次要结局
- Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index(6 weeks)
- Subject's Global Assessment of Arthritis Status(6 weeks)
- Cognitive Functioning in Patients with Chronic Pain(6 weeks)
研究者
研究点 (31)
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