A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of V120083 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 29
- 主要终点
- Daily "Average Pain Over the Last 24 Hours" Score at Week 4
研究概览
简要总结
The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily compared to placebo in subjects with moderate to severe chronic pain due to 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 80 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
V120083 30 mg
V120083 30-mg capsules taken orally twice daily
干预措施: V120083 (Drug)
V120083 30 mg
V120083 30-mg capsules taken orally twice daily
干预措施: Placebo (Drug)
V120083 60 mg
V120083 60-mg (2 x 30 mg) capsules taken orally twice daily
干预措施: V120083 (Drug)
V120083 60 mg
V120083 60-mg (2 x 30 mg) capsules taken orally twice daily
干预措施: Placebo (Drug)
Naproxen
Naproxen 500-mg capsules taken orally twice daily
干预措施: Naproxen (Drug)
Naproxen
Naproxen 500-mg capsules taken orally twice daily
干预措施: Placebo (Drug)
Placebo
Capsules to match V120083 and/or naproxen taken orally twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Daily "Average Pain Over the Last 24 Hours" Score at Week 4
时间窗: Week 4
At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
次要结局
- Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score(4 Weeks)
- Responder to Treatment (Calculated as the Percentage Reduction of "Average Pain Over the Last 24 Hours") at Week 4(Week 4)
- Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary(4 Weeks)
- Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary(4 Weeks)
- Average Daily "Pain Right Now" Score Collected by e-Diary(4 Weeks)
- Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale(4 Weeks)
- Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale(4 Weeks)
- Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale(Weeks 1, 2 and 4)
- Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale(4 Weeks)
- Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score(4 Weeks)
- Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)(4 Weeks)
- Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score(4 Weeks)
- European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status(4 Weeks)
- Patient Global Impression of Change (PGIC)(4 Weeks)
- Supplemental Analgesic Medication Use(Up to 28 days)
- Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)(Baseline up to 4 Weeks)
- Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score(Week 4)