NCT00637949已完成3 期
A 6-Week Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Clinical Saftey Study to Evaluate Incidence of Predefined Gastrointestinal Adverse Events and Peripheral Edema in Subjects With Primary Osteoarthritis Treated With COX189 400 mg o-do Using Rofecoxib 25 mg o.d. as a Comparator
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
- Novartis
- 入组人数
- 309
- 主要终点
- Incidence of at least one of seven predefined gastrointestinal adverse events
研究概览
简要总结
This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=50 years old
- •Primary osteoarthritis in hip, hand, knee or spine for at least 3 month
- •Pain in the target joint of moderate intensity
- •Written informed consent
排除标准
- •Secondary osteoarthritis
- •Active upper gastro intestinal tract ulceration
- •Inflammatory joint disease
- •Clinically significant hepatic or renal disease
- •Other in and exclusion criteria may apply
研究组 & 干预措施
1
Experimental
干预措施: lumiracoxib (Device)
2
Active Comparator
干预措施: rofecoxib (Drug)
结局指标
主要结局
Incidence of at least one of seven predefined gastrointestinal adverse events
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
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