A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Difference in average pain intensity on Brief Pain Inventory
研究概览
简要总结
This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive duloxetine or placebo during the course of the trial. All subjects will, in fact, receive placebo for the first two weeks. All subjects will then be placed on 60-90mg per day of duloxetine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of duloxetine treatment).
Study Hypothesis:
In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 60-90 mg Duloxetine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo(> 30% reduction after Duloxetine treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-80
- •Physician diagnosis of OA in hip, knee or spine.
- •Significant activity limitation due to pain for at least one month on the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) and average pain >5/10 on Brief Pain Inventory despite adequate treatment with acetaminophen or NSAIDs. [This will identify an OA group with significant psychological distress and a desire for treatment.]
- •Depression status is not restricted, but will be monitored with PRIME-MD interview and the SCL-
- •We anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation.
排除标准
- •Cannot read and write English
- •Significant cognitive impairment
- •History of psychosis or mania
- •Current suicidal ideation
- •Current substance abuse or dependence
- •Current use of opioids or any antidepressant medication
- •Use of investigational drug within the past month
研究组 & 干预措施
A
All subjects receive placebo for the first two weeks and then duloxetine for the next 10 weeks, but they are blind to what they are receiving.
干预措施: duloxetine (Drug)
结局指标
主要结局
Difference in average pain intensity on Brief Pain Inventory
时间窗: between 2 weeks and 12 weeks
Difference in pain intensity on Western Ontario McMasters University Osteoarthritis Index (WOMAC)
时间窗: Difference between 2 weeks and 12 weeks
次要结局
- Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC)(Difference between 2 and 12 weeks)
- Difference in role function as assessed by the Sheehan Disability Scales(Difference between 2 and 12 weeks)
- Difference on observed physical function as assessed by the Aggregated Locomotor Function score(Difference between 2 and 12 weeks)