NCT00807846已完成4 期
A Phase 4, 6-week, Randomized Double Blind, Multicenter, Active-controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.39 个研究点 分布在 10 个国家目标入组 201 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 39
- 主要终点
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
研究概览
简要总结
This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA)
- •Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible
- •≥2 years of age and <18 years of age prior to the Baseline visit
- •Body weight ≥10 kg at the Baseline visit
- •Candidate for chronic NSAID therapy in the Investigator's judgment
排除标准
- •Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
- •Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA)
- •Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded
- •Subjects with active Systemic JIA should not be enrolled
研究组 & 干预措施
Celecoxib
Experimental
干预措施: Celecoxib (Drug)
Naproxen
Experimental
干预措施: Naproxen (Drug)
结局指标
主要结局
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
时间窗: 6 Weeks/Final Visit
Value at 6 weeks minus value at baseline.
次要结局
- Change From Baseline in SBP at Week 4.(4 weeks)
- Change From Baseline to Week 2 in SBP.(2 weeks)
- Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.(Week 6/Final Visit)
- Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.(2 weeks)
- Change From Baseline in DBP at Week 4.(4 weeks)
- Change From Baseline in DBP at Week 6/Final Visit(6 weeks)
- Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.(Week 6/Final Visit)
- Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.(6 weeks)
- Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.(6 weeks)
研究者
研究点 (39)
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