NCT00541489已完成3 期
A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip
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
- 800
- 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 hip
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 randomized, double-blind, parallel group, multicenter study 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 hip
- •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
- •Clinically relevant abnormal ECG
- •A history of alcohol or drug abuse
- •Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
- •Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
- •Candidates for imminent joint replacement
- •Participation within 30 days prior to screening in another investigational study
研究组 & 干预措施
1
Placebo Comparator
干预措施: Placebo (Drug)
2
Active Comparator
Naproxen 500 mg
干预措施: Naproxen (Drug)
3
Experimental
Naproxcinod 750 mg
干预措施: Naproxcinod (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 hip
次要结局
未报告次要终点
研究者
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