NCT00648141已完成3 期
A 12-Week Symptomatic Effect Evaluation to Compare Celecoxib 200 mg QD, Celecoxib 200 mg BID and Diclofenac 75 mg SR BID in Patients With Ankylosing Spondylitis
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
- Pfizer
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- Change from baseline in global pain intensity as assessed by visual analog scale (VAS)
研究概览
简要总结
To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ankylosing spondylitis defined according to modified New York criteria, and with axial involvement
- •Requiring daily treatment with nonsteroidal anti-inflammatory drugs during the previous 30 days
排除标准
- •Patients with inflammatory enterophathy, and with extra-articular manifestations
- •Patients with known vertebral compression
- •Received corticosteroids 6 weeks prior to the baseline visit; patients on stable dose of prednisolone equivalents ≤ 10 mg/ day for at least 14 days before randomization were permitted
研究组 & 干预措施
A
Experimental
干预措施: Celecoxib (Drug)
B
Experimental
干预措施: Celecoxib (Drug)
C
Active Comparator
干预措施: Diclofenac (Drug)
结局指标
主要结局
Change from baseline in global pain intensity as assessed by visual analog scale (VAS)
时间窗: Week 12
Responder rates, defined as 50% improvement in VAS from baseline
时间窗: Week 12
次要结局
- Patient's and physician's global assessment of disease activity(Weeks 1, 2, 6, and 12)
- Spinal pain(Weeks 1, 2, 6, and 12)
- Short Form-12(Weeks 1, 2, 6, and 12)
- Adverse events(Week 12)
- Physical evaluation(Week 12)
- Laboratory tests(Week 12)
- Nocturnal pain(Weeks 1, 2, 6, and 12)
- Composite Bath Ankylosing Spondylitis Disease Activity Index(Weeks 1, 2, 6, and 12)
- Bath Ankylosing Spondylitis Metrology Index(Weeks 1, 2, 6, and 12)
- Change from baseline in C-reactive protein measurement(Week 12)
- Responder rates, defined as 50% improvement in VAS from baseline(Weeks 1, 2, and 6)
- Mobility parameters(Weeks 1, 2, 6, and 12)
- Change from baseline in Assessments in Ankylosing Spondylitis 20 score(Weeks 1, 2, 6, and 12)
- Change from baseline in global pain intensity(Weeks 1, 2, and 6)
- Bath Ankylosing Spondylitis Functional Index(Weeks 1, 2, 6, and 12)
研究者
研究点 (1)
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