NCT00652808已完成3 期
Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg QD and Naproxen 500 mg BID in Treating the Signs and Symptoms of Osteoarthritis of the Knee
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
- 265
- 试验地点
- 1
- 主要终点
- Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
研究概览
简要总结
This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed according to the modified American College Rheumatology criteria)
- •Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS
- •Patients had not received any NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) prior to the Baseline Visit
排除标准
- •Diagnosis of inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain syndrome that, in the Investigator's opinion, would interfere with the assessment of the Index Knee
- •Symptomatic anserine bursitis or acute joint trauma of the Index Knee
- •Arthroscopy performed on the Index Knee within the past 12 months
- •Complete loss of articular cartilage of the Index Knee
- •Administration of oral, or intramuscular, intravenous, or soft tissue injections of corticosterosteroids within 4 weeks prior to screening visit
- •Administration of intra-articular injection of corticosteroids or hyaluronic acid preparation in the Index Knee within 3 months or 6 months, respectively
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 using a Visual Analogue Scale (OA-Pain VAS)
时间窗: Week 6
次要结局
- WOMAC OA Physical Function(Week 2 and Week 6)
- WOMAC OA Stiffness Index(Week 2 and Week 6)
- Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)(Week 2)
- Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)(Week 2 and Week 6)
- adverse events(Continuous)
- Physician's Global Assessment of Arthritis Pain(Week 2 and Week 6)
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index(Week 2 and Week 6)
- WOMAC OA Pain Index(Week 2 and Week 6)
研究者
研究点 (1)
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