NCT01264965终止4 期
Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Pain Self-report on the Brief Pain Inventory and WOMAC
研究概览
简要总结
To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and brief physical performance measure) and to determine if cognitive status modifies this relationship.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 65
- •Pain at least 3 months duration
- •Pain greater in lower extremity than other anatomical site with ambulation
- •Pain self-report of moderate intensity of higher on an average day
- •Community-dwelling
- •Physician states participants have decision-making capacity to enroll into the trial
- •Participants with cognitive impairment have a reliable caregiver
- •Inadequate pain relief from NSAIDS and/or acetaminophen in the past
排除标准
- •Current cancer requiring chemotherapy
- •History of addiction to opioids or other controlled substance
- •Consumes more than 2 alcoholic drinks a day
- •Severe balance disturbance
- •Intra-articular steroid injection in the past 6 weeks
研究组 & 干预措施
Acetaminophen
Active Comparator
干预措施: extra strength acetaminophen (Drug)
Long Acting Oxycodone
Active Comparator
干预措施: long acting oxycodone (Drug)
结局指标
主要结局
Pain Self-report on the Brief Pain Inventory and WOMAC
时间窗: 14 days
次要结局
- Discontinuation of Study Drug, Short Physical Performance Battery(14 days)
研究者
研究点 (1)
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