NCT01688934已完成2 期
A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 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
- 已完成
- 入组人数
- 230
- 试验地点
- 18
- 主要终点
- Western Ontario and McMaster OA Index (WOMAC) Pain Score
研究概览
简要总结
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
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
- •Subjects with moderate pain due to OA of the knee as their primary pain condition.
- •Subjects with diagnostic criteria for primary pain condition (American college of Rheumatology [ACR] clinical and radiographic criteria):
- •At least 1 of the following in addition to knee pain: age >50, stiffness <30 min, crepitus on active motion, and
- •Kellgren-Lawrence (K-L) grade ≥ 2 radiographic evidence within the past 2 years.
排除标准
- •Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
- •Subjects who cannot or will not agree to stop all concomitant analgesic medications, apart from specified protocol supplemental analgesic medications.
- •Subjects with history of seizures within the past 5 years.
- •Subjects who use opioids more than 4 days per week.
- •Pain-condition-specific exclusions:
- •Subjects who received local pain-control procedures, including intra- articular steroid injection in the study knee or intramuscular steroid injection at any site within 6 weeks of entering the study or hyaluronate injection in the study knee within 12 weeks of entering the study.
- •Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study.
- •Active-comparator-related exclusions:
- •Subjects who are allergic to or cannot tolerate naproxen or acetaminophen, including history of NSAID-induced asthma, or nasal polyps;
- •Subjects with history of bleeding disorders or history of documented gastrointestinal ulcer disease.
- •Other protocol specific inclusion/exclusion criteria may apply.
研究组 & 干预措施
V116517 - 50 mg
Experimental
V116517 50-mg tablets
干预措施: V116517 50-mg tablets (Drug)
V116517 - 50 mg
Experimental
V116517 50-mg tablets
干预措施: Placebo (Drug)
V116517 - 30 mg
Experimental
V116517 30-mg tablets
干预措施: V116517 30-mg tablets (Drug)
V116517 - 30 mg
Experimental
V116517 30-mg tablets
干预措施: Placebo (Drug)
Naproxen 500 mg
Active Comparator
Naproxen 500-mg capsules
干预措施: Naproxen 500-mg capsules (Drug)
Naproxen 500 mg
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
Western Ontario and McMaster OA Index (WOMAC) Pain Score
时间窗: Week 4
次要结局
- WOMAC Physical Function Score(Week 4)
- Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain(Week 4)
- Patient Global Impression of Change (PGIC)(Week 4)
- WOMAC Stiffness Score(Week 4)
- Supplemental Analgesic Medication Use(Over 4 weeks)
研究者
研究点 (18)
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
Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following BunionectomyPain, PostoperativeNCT03997812Vivozon, Inc.60
终止
2 期
An Analgesic Study to of V117957 for the Treatment of Postsurgical Pain Due to Third Molar ExtractionPostsurgical Pain Due to Third Molar ExtractionNCT01900795Purdue Pharma LP114
终止
2 期
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following BunionectomyPain, Post-operativeNCT02169336Baudax Bio95
已完成
2 期
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following GastrectomyPost-Operative PainNCT02844725Vivozon, Inc.60