NCT00650624已完成2 期
A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg QD Versus Placebo In Patients With OA Of The Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- WOMAC (Western Ontario and McMaster Universities) OA Pain Index
研究概览
简要总结
To determine the therapeutic dose range of valdecoxib by comparing the efficacy of three dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and symptoms of osteoarthritis of the knee. To assess safety and tolerability of multiple doses of valdecoxib in patients with osteoarthritis 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with symptomatic OA of the knee by the American College of Rheumatology (ACR) criteria and a Functional Capacity Classification (FCC) of I - III at Screening Visit and were walking
- •At the Baseline visit, eligible patients were to have Patient's Assessment of Arthritis Pain VAS ≥ 40 mm and Patient's & Physician's Global Assessment of Arthritis of "Poor" or "Very Poor"
排除标准
- •Patients unable to walk generally
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: valdecoxib (Drug)
Arm 3
Active Comparator
干预措施: valdecoxib (Drug)
Arm 4
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
WOMAC (Western Ontario and McMaster Universities) OA Pain Index
时间窗: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)
次要结局
- WOMAC OA composite index(screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6)
- WOMAC OA pain index, stiffness index, physical function index, and composite index(screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6)
- Incidence of and time to withdrawal due to lack of efficacy(weeks 2, 4, and 6)
- patients' and physicians' and 'categorical' global assessment of arthritis(screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6)
- WOMAC OA physical function index(screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6)
- patient's assessment of arthritis pain (Visual Analog Scale, VAS)(screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6)
- WOMAC OA stiffness index(screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Analgesic Efficacy Of Valdecoxib In Patients Following Bunion SurgeryPain, Post-surgicalNCT00653354Pfizer360
已完成
3 期
Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy SurgeryPainHallux ValgusNCT00683137Pfizer450
已完成
3 期
A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In TaiwanOsteoarthritisNCT00648258Pfizer130
已完成
3 期
Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the KneeKneeOsteoarthritisNCT00652808Pfizer265
终止
4 期
A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle SprainAcute PainNCT00657449Pfizer45