NCT02847702终止2 期
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo Controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of VM902A in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 1
- 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, safety, and tolerability of VM902A 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 75 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
VM902A 200 mg
Experimental
VM902A 200-mg Capsules
干预措施: VM902A 200-mg Capsules (Drug)
VM902A 200 mg
Experimental
VM902A 200-mg Capsules
干预措施: Placebo (Drug)
VM902A 400 mg
Experimental
VM902A 400-mg Capsules (2 x 200-mg capsules)
干预措施: VM902A 400-mg Capsules (Drug)
VM902A 400 mg
Experimental
VM902A 400-mg Capsules (2 x 200-mg capsules)
干预措施: Placebo (Drug)
Naproxen
Active Comparator
Naproxen 500-mg Capsules
干预措施: Naproxen 500-mg Capsules (Drug)
Naproxen
Active Comparator
Naproxen 500-mg Capsules
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo
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
次要结局
- Western Ontario and McMaster OA Index (WOMAC) Pain Severity Subscale Score(Week 4)
- Western Ontario and McMaster OA Index (WOMAC) Physical Function Subscale Score(Week 4)
- Average Daily "Pain Right Now" Score at Week 4(Week 4)
- Western Ontario and McMaster OA Index (WOMAC) - Total Scores(Week 4)
- Weekly "Average Pain Over the Last 24 Hours" at Week 4(Week 4)
- Western Ontario and McMaster OA Index (WOMAC) Stiffness Subscale Score(Week 4)
- Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Scores(Week 4)
- Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score(Week 4)
- Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score(Week 4)
- Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)(Week 4)
- EuroQol-5D (EQ-5D) to Measure Health Status(Week 4)
- Patient Global Impression of Change (PGIC) at the End of the Double-blind Period(Week 4)
- Supplemental Analgesic Medication Use(Days 1 - 28)
- Responder to Treatment(Week 4)
- Hospital Anxiety and Depression Scale (HADS) Score(Baseline to Week 4)
- Columbia-Suicide Severity Rating Score (C-SSRS)(Baseline to Week 4)
- Survey of Autonomic Symptoms (SAS) Score(Baseline to Week 4)
- Kellgren-Lawrence Classification (K-L) Score(Baseline to Week 4)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)PainPostherpetic NeuralgiaNCT01688947Purdue Pharma LP105
已完成
2 期
Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the KneePainOsteoarthritis, KneeNCT01688934Purdue Pharma LP230
已完成
2 期
Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following BunionectomyPain, PostoperativeNCT03997812Vivozon, Inc.60
已完成
2 期
A Study of TRV130 for the Treatment of Pain After BunionectomyAcute PainNCT02100748Trevena Inc.333
已完成
2 期
A Study of TRV130 for the Treatment of Pain After AbdominoplastyPainNCT02335294Trevena Inc.200