NCT00504127已完成3 期
A Phase 3, 53 Weeks Study on Analgesic Efficacy and Safety of Naproxcinod (HCT 3012): 26-Week, Randomized, Parallel-Group, Double-Blind, Placebo (13 Weeks)- and Naproxen (26 Weeks)-Controlled, Multicenter Study of Naproxcinod (375 mg Bid and 750 mg Bid) With a 26-Week Naproxen-Controlled Safety Follow-up in Subjects With Osteoarthritis of the Knee, and a 1-week Post-treatment Safety Follow-up
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- NicOx
- 入组人数
- 1,020
- 主要终点
- To show that both doses of Naproxcinod (375 mg twice daily [bid] and 750 mg bid) were superior to placebo in relieving osteoarthritis (OA) signs and symptoms in subjects with OA of the knee at Week 13.
研究概览
简要总结
To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis
详细描述
This is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen. The first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.
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 Woman (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 anti-coagulant
- •Clinical relevant abnormal ECG
- •A history of alcohol or drug abuse
- •Candidates for imminent joint replacement
- •Participation within 30 days prior to screening in another investigational study
研究组 & 干预措施
naproxcinod 375 mg bid
Experimental
干预措施: Naproxcinod 375 mg bid (Drug)
naproxcinod 750 mg bid
Experimental
干预措施: Naproxcinod 750 mg bid (Drug)
naproxen 500 mg bid
Active Comparator
干预措施: Naproxen 500 mg bid (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
To show that both doses of Naproxcinod (375 mg twice daily [bid] and 750 mg bid) were superior to placebo in relieving osteoarthritis (OA) signs and symptoms in subjects with OA of the knee at Week 13.
时间窗: 13 weeks
次要结局
- To assess the efficacy of naproxcinod compared to naproxen 500 mg bid in relieving OA signs and symptoms in subjects with OA of the knee(52 weeks)
- To evaluate the effect on blood pressure (BP) of both doses of naproxcinod, placebo, and naproxen 500 mg bid, as measured by the office BP monitoring in a population of OA subjects(52 weeks)
- To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach(52 weeks)
- To assess if there were any radiological changes at Week 52 in naproxcinod compared with naproxen subjects (target joint radiographs were taken at Screening and after 52 weeks of treatment, or if early termination occurred after Week 26)(52 weeks)
- To compare the general safety and tolerability of both doses of naproxcinod versus naproxen 500 mg bid up to 52 weeks and with one Week post treatment follow up (Week 53)(53 weeks)
研究者
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