A 6-Week, Randomized, Double-Blind, Parallel-Group Study To Evaluate The Symptomatic Effects And Safety Of Celecoxib 200mg QD Compared To Diclofenac 75mg SR QD In Chinese Patients With Ankylosing Spondylitis, With 6-Week Extension Phase Treatment On Celecoxib 400 Mg QD Or Maintaining Double-Blind Phase Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Participant's Assessment of Global Pain Intensity at Baseline
研究概览
简要总结
This is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the 1984 Modified New York Criteria for Classification of Ankylosing Spondylitis
- •With axial involvement
- •Without peripheral joint involvement (synovitis) at the time of study entry, (excluding involvement of the hips, knees and shoulders)
- •Need for daily treatment with NSAIDs during the previous 30 days before study entry
排除标准
- •Known inflammatory enteropathy (eg, ulcerative colitis, Crohn's disease, etc)
- •Presence of extra-articular manifestations (eg, uveitis, endocarditis, etc.)
- •Known vertebral compression
- •Need for a corset during the study
研究组 & 干预措施
Celecoxib 200 mg QD
干预措施: Celecoxib (Drug)
Diclofenac SR 75 mg QD
干预措施: Diclofenac SR (Drug)
结局指标
主要结局
Participant's Assessment of Global Pain Intensity at Baseline
时间窗: Baseline
100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain.
Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6
时间窗: Baseline, Week 6
100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of less than (\<) 0 indicated improvement.
次要结局
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6(Baseline, Weeks 2, 4, 6)
- Change From Baseline in BASDAI at Week 12(Baseline, Week 12)
- Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20(Weeks 2, 4, 6, 12)
- Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6(Baseline, Weeks 2, 4, 6)
- Change From Baseline in Nocturnal Pain at Week 12(Baseline, Week 12)
- Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12(Baseline, Week 12)
- Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4(Baseline, Weeks 2, 4)
- Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12(Baseline, Week 12)
- Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6(Baseline, Weeks 2, 4, 6)
- Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6(Baseline, Weeks 2, 4, 6)
- Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12(Baseline, Week 12)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6(Baseline, Weeks 2, 4, 6)
- Change From Baseline in BASFI at Week 12(Baseline, Week 12)
- Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6(Baseline, Weeks 2, 4, 6)
- Change From Baseline in Fingertips to Floor Distance at Week 12(Baseline, Week 12)
- Change From Baseline in Chest Expansion at Weeks 2, 4, and 6(Baseline, Weeks 2, 4, 6)
- Change From Baseline in Chest Expansion at Week 12(Baseline, Week 12)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6(Baseline, Week 6)
- Change From Baseline in ESR at Week 12(Baseline, Week 12)
- Change From Baseline in C-Reactive Protein (CRP) at Week 6(Baseline, 6 Weeks)
- Change From Baseline in CRP at Week 12(Baseline, Week 12)
- Percentage of Participants With Concomitant Use of Paracetamol(Week 6)
- Percentage of Days With Concomitant Administration of Paracetamol(Week 6)
- Paracetamol Tablets Taken Per Day by Participant(Week 6)