跳至主要内容
临床试验/NCT00542087
NCT00542087已完成3 期

A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip

Organon and Co0 个研究点目标入组 516 人开始时间: 2002年3月22日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
516
主要终点
This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).

研究概览

简要总结

To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip
  • Has a history of treatment with NSAIDs with positive therapeutic benefit
  • Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity
  • Females who are able to have children must have negative urine pregnancy tests

排除标准

  • Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease
  • History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months
  • Requires joint replacement

结局指标

主要结局

This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).

次要结局

  • The study drug will be safe and well tolerated during the course of the study.

研究者

申办方类型
Industry
责任方
Sponsor

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