A Randomized, Double-Blind, Long-Term Comparative Study Evaluating the Safety and Efficacy of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 581
- 主要终点
- Change from baseline in the WOMAC Osteoarthritis Index pain subscale score at Month 6 or at the final visit at the time of subject discontinuation from baseline during the first six months after baseline.
研究概览
简要总结
The purpose of this study is to compare the long-term safety and effectiveness of acetaminophen (4000 mg per day) and naproxen (750 mg per day) in the treatment of osteoarthritis of the hip or knee.
详细描述
This is a randomized, double-blind study to compare the long term safety profile and effectiveness of acetaminophen, given at a dose of 1000 mg every four to six hours, and naproxen, given at a dose of 375 mg twice daily (with matching placebo given four times daily to maintain the blind), in the treatment of osteoarthritis of the hip or knee. There are two groups of subjects. Group 1 has approximately 480 subjects randomized and a treatment duration of 12 months. Group 2 has approximately 80 subjects randomized and a treatment duration of 6 months. The primary measure of efficacy is the change from baseline in the WOMAC Osteoarthritis Index pain subscale at month 6. Safety evaluations, throughout the course of the study, include monitoring adverse events, laboratory tests and assessments of vital signs including respiration rate, pulse, blood pressure, and body weight. Subjects are instructed to take a dose of medication orally, every 4-6 hours. The acetaminophen subjects take a total daily dose of 4 g of acetaminophen. The naproxen subjects a total daily dose of 750 mg of naproxen. The treatment duration is 12 and 6 months in Group 1 and Group 2, respectively.
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
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the hip or knee for a minimum of six months duration requiring treatment with either an analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months
- •History of osteoarthritis of the hip or knee characterized by pain of mild or moderate intensity
- •Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria
- •Physical ability must be either American College of Rheumatology (ACR) Functional Class I or II
- •Following the washout period, reports mild to moderately severe pain over the previous 24 hours and demonstrates a minimum increase of 20% in the WOMAC Osteoarthritis Index pain subscale score, relative to the screening score.
排除标准
- •History of surgery, including arthroscopy, or major trauma to the study joint in the previous 12 months
- •Radiographic evidence of severe osteoarthritis of the study joint based on the Kellgren and Lawrence radiographic criteria of grade 4 osteoarthritis
- •Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination after the washout period
- •Morning stiffness of >30 minutes duration
- •Significantly incapacitated or disabled and would be categorized as ACR Functional Class III (able to perform only few or none of the duties of usual occupation or self-care) or IV (largely or wholly incapacitated), or unable to walk without assistive devices
研究组 & 干预措施
001
acetaminophen 4 grams daily for 12 months
干预措施: acetaminophen (Drug)
002
naproxen 750 mg daily for 12 months
干预措施: naproxen (Drug)
003
acetaminophen 4 grams daily for six months
干预措施: acetaminophen (Drug)
004
naproxen 750 mg daily for six months
干预措施: naproxen (Drug)
结局指标
主要结局
Change from baseline in the WOMAC Osteoarthritis Index pain subscale score at Month 6 or at the final visit at the time of subject discontinuation from baseline during the first six months after baseline.
次要结局
- Change from baseline to Month 6 (or Month 12 for subjects participating in Group 1) or final visit in the WOMAC Osteoarthritis Index stiffness and physical function subscale scores.