NCT01985165Unknown4 期
A Multicenter，Open-label Phase Ⅳ Trial of Imrecoxib in Treatment of Knee Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 2,400
- 试验地点
- 19
- 主要终点
- Change from baseline in Patient's Assessment of Arthritis Pain, according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)3.0
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the treatment of patients with knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged form 18 years to 75 years old
- •Diagnosed with osteoarthritis of the knee according to the American College of Rheumatology
- •Functional capacity class of Ⅰ-Ⅲ
排除标准
- •Unstable angina
- •History of myocardial infarction within the last 6 months
- •Stroke in the 6 months before screening
- •New York Heart Association class Ⅲ-Ⅳ congestive heart-failure
- •Systolic blood pressure>180mmHg,and/or Diastolic blood pressure>100mmHg
- •Peptic ulcer
- •Known contraindications to non-steroidal anti-inflammatory drug（NSAID）
- •Received aspirin within 3 days of baseline visit
- •Aspirin dosage>150mg/d
- •Known to be Allergic to sulfa and COX-2 inhibitors
- •Pregnancy or lactation
- •Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>2 times upper limit of normal
- •Blood urine nitrogen>1.5 times upper limit of normal
研究组 & 干预措施
Imrecoxib
Experimental
0.1g,BID,po
干预措施: Imrecoxib (Drug)
结局指标
主要结局
Change from baseline in Patient's Assessment of Arthritis Pain, according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)3.0
时间窗: Baseline to Week 24
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: Baseline to week 24
次要结局
未报告次要终点
研究者
研究点 (19)
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