NCT00433290已完成3 期
Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain
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
- 256
- 试验地点
- 1
- 主要终点
- Change in Brief Pain Inventory (BPI) 24-hour Average Rating
研究概览
简要总结
The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients with osteoarthritis knee pain.
排除标准
- •Serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
- •Previous exposure to duloxetine.
研究组 & 干预措施
A
Experimental
干预措施: Duloxetine (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Brief Pain Inventory (BPI) 24-hour Average Rating
时间窗: Baseline, Week 4, Week 7, Week 13
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Changes are timepoint minus baseline.
次要结局
- Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)(13 Weeks)
- Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)(Baseline and 13 Weeks)
- Number of Participants Who Responded to Treatment at 13 Week Endpoint(13 Weeks)
- Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference(Baseline and 13 Weeks)
- Adverse Events Reported as Reason for Discontinuation(over 13 weeks)
- Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes(Baseline and 13 Weeks)
- Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride(Baseline and 13 Week Endpoint)
- Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Vital Signs - Weight(Baseline and 13 Weeks)
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders(Baseline and 13 Weeks)
- Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint(13 Weeks)
- Adverse Events Reported as Reason for Discontinuation in Nonresponders(over 13 Weeks)
研究者
研究点 (1)
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