A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY OF THE EFFECT OF MELOXICAM IN MAINLAND CHINESE SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE KNEE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 408
- 试验地点
- 25
- 主要终点
- WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary
研究概览
简要总结
This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis in this population.
详细描述
To validate culturally the WOMAC tool in mainland China and observe the different response of meloxicam and placebo in a patient population 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
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are required to meet the following criteria to be eligible for Randomization into this study:
- •Male or female Chinese subjects, 18-75 years of age;
- •Subjects must have a diagnosis of OA of the index knee based on American College of Rheumatology criteria with X ray confirmation (a Kellgren Lawrence x ray grade of greater than or equal to 2) (Kellgren J. & Lawrence J, 1957)
- •Subjects must have have an NRS and a WOMAC pain sub scale score of 4 at Screening and at Baseline based on four daily diary entries
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •History of other disease that may involve the index (painful) knee including inflammatory joint diseases or have had recent surgical intervention on the knee.
- •Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication. History of or active gastrointestinal disease (eg, inflammatory bowel disease), a chronic or acute renal or hepatic disorder, or a significant coagulation defect.
- •Signs and symptoms of clinically significant cardiac disease
研究组 & 干预措施
Meloxicam
干预措施: Meloxicam (Drug)
Placebo
2 Placebo capsules once a day for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary
时间窗: Baseline (Day 1)
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 1 by Using a Paper Worksheet and a Personalized Electronic LogPad System (E-diary)
时间窗: Screening 1 (Visit 1: Days -21 to -14)
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary
时间窗: Screening 2 (Visit 2: Days -14 to -10)
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary
时间窗: Visit 8 (Week 12)
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
Change From Baseline in WOMAC Pain Subscale Scores at Week 12
时间窗: Baseline and Week 12
WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.
次要结局
- Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12(Baseline, Weeks 2, 4, 8 and 12)
- Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12(Baseline, Weeks 2, 4, 8 and 12)
- Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12(Baseline and Week 12)
- Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12(Baseline, Weeks 2, 4, 8 and 12)
- Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12(Baseline, Weeks 2, 4, 8 and 12)
- Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12(Baseline and Week 12)
- Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12(Baseline, Weeks 2, 4, 8 and 12)
- Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12(Baseline, Weeks 2, 4, 8 and 12)
- Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12(Baseline and Week 12)