301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Followed by Its Extension (301E): A Parallel, Randomized, Open-Label, Multicenter, 52-Week Follow-up Safety Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Subjects With Osteoarthritis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- NicOx
- 入组人数
- 918
- 主要终点
- The primary objective of this study is to show that naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the knee at 13 weeks and to collect long term safety data
研究概览
简要总结
To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.
详细描述
This is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.
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
- •Men and women (40 or older) with a diagnosis of primary OA of the knee
- •Must be a current chronic user of NSAIDS or acetaminophen
- •Must discontinue all analgesic therapy at screening
排除标准
- •Uncontrolled hypertension or diabetes
- •Hepatic or renal impairment
- •Current or expected use of anticoagulant
- •A history of alcohol or drug abuse
- •Candidates for imminent joint replacement
- •Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
- •Current medical disease that could confound or interfere with the evaluation of efficacy
- •Participation within 30 days prior to screening in another investigational study
研究组 & 干预措施
Naproxcinod 375 mg bid
干预措施: Naproxcinod 375 mg (Drug)
Naproxen 500 mg bid
干预措施: Naproxen (Drug)
Placebo bid
At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.
干预措施: Placebo (Drug)
Naproxcinod 750 mg bid
干预措施: Naproxcinod 750 mg (Drug)
结局指标
主要结局
The primary objective of this study is to show that naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the knee at 13 weeks and to collect long term safety data
时间窗: 13 weeks / long term
次要结局
未报告次要终点