Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Study Evaluating the Efficacy of PN400 (VIMOVO) Twice Daily (Bid) and Celecoxib Once Daily (qd) in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 614
- 试验地点
- 1
- 主要终点
- Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline
研究概览
简要总结
We will evaluate the efficacy of PN400 and an active comparator in patients that have Osteoarthritis of the knee.
详细描述
3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ARM 1 PN 400 (VIMOVO)
PN400: 500 mg naproxen/20 mg esomeprazole
干预措施: PN 400 (VIMOVO) (Drug)
ARM 1 PN 400 (VIMOVO)
PN400: 500 mg naproxen/20 mg esomeprazole
干预措施: Rescue Antacid (Drug)
Arm 2 (celebrex)
Celecoxib 200 mg
干预措施: celebrex (Drug)
Arm 2 (celebrex)
Celecoxib 200 mg
干预措施: Rescue Antacid (Drug)
Arm 3 (placebo)
sugar pill
干预措施: Placebo (Drug)
Arm 3 (placebo)
sugar pill
干预措施: Rescue Antacid (Drug)
结局指标
主要结局
Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline
时间窗: Baseline and 12 weeks
Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).
Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline
时间窗: 12 weeks
WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain from baseline (in mm). The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).
Change in Patient Global Assessment (PGA) Subscore From Baseline
时间窗: 12 weeks
PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.
次要结局
- American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.(Baseline and Day 7)
- Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline(Week 6)
- Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline(Week 6)
- Change in Patient Global Assessment (PGA) Subscore From Baseline(Week 6)
- Antacid Tablet Use(12 weeks)
- Modified Severity of Dyspepsia Assessment (mSODA)(Baseline to 12 weeks)
- Percent of Days With no Heartburn (Heartburn Resolution)(12 weeks)
- Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms(daily during 12 weeks)
- The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event(daily during 12 weeks)