NCT00648258已完成3 期
A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg QD And Naproxen 500mg BID In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan
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
- 130
- 试验地点
- 1
- 主要终点
- Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
研究概览
简要总结
To evaluate the efficacy, safety, and tolerability of valdecoxib by comparing valdecoxib 10 mg daily (QD) with naproxen 500 mg twice daily (BID) in treating the signs and symptoms of osteoarthritis (OA) of the knee or hip. The study was designed to collect comparative information for the local population (Taiwan).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of hip OA, which was having hip pain and meeting criteria for at least 2 of the following: a. Westergren erythrocyte sedimentation rate of < 20 mm/hr; b. radiographic femoral or acetabular osteophytes or c. radiographic joint space narrowing
- •Knee OA diagnosis required diagnosing (by modified American College of Rheumatology criteria) OA of the knee with pain plus at least one of the following: a. Age> 50 years old, b. Stiffness < 30 minutes, c. crepitus on active motion and radiographic evidence of OA of the knee, defined as presence of osteophytes or joint space narrowing
- •Symptomatic OA of the knee or hip was determined at the Baseline Visit, if the Patient's Assessment of Arthritis Pain was at least 40 mm VAS, Patient's and the Physician's Global Assessment of Arthritis was "poor" or "very poor"
排除标准
- •Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: valdecoxib (Drug)
Arm 2
Active Comparator
干预措施: naproxen (Drug)
结局指标
主要结局
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
时间窗: Week 6
次要结局
- WOMAC OA stiffness index(Week 2 and Week 6)
- Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)(Week 2)
- Patient's Global Assessment of Arthritis(Week 2 and Week 6)
- WOMAC OA physical function(Week 2 and Week 6)
- WOMAC OA pain index(Week 2 and Week 6)
- Physician's Global Assessment of Arthritis(Week 2 and Week 6)
- Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index(Week 2 and Week 6)
研究者
研究点 (1)
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