NCT00242489已完成2 期
A Placebo-Controlled, Parallel-Group, Double-Blind Study to Assess Safety and to Define the Clinically Effective Dose Range of MK0663 in Patients With Osteoarthritis of the Knee, Followed by a Double-Blind, Active-Comparator-Controlled Extension.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,167
- 主要终点
- WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of 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
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
- •Positive therapeutic effect from prior NSAID therapy.
- •Worsening of symptoms upon withdrawal of prior treatment.
- •With the exception of OA, in otherwise good health
排除标准
- •Weight no more than 280 pounds (male or female).
- •Recent, sustained use of gastroprotective agents.
- •History of arthroscopy of the affected knee within 6 months prior to study entry.
- •History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.
结局指标
主要结局
WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)
次要结局
- Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy
研究者
相似试验
已完成
3 期
A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)Acute Pain Following a Total Abdominal HysterectomyNCT00788710Organon and Co430
已完成
3 期
Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)Pain, PostoperativeNCT00820027Organon and Co776
已完成
3 期
A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)Spondylitis, AnkylosingNCT01208207Organon and Co1,015
Unknown
4 期
Evaluation of the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients With Neuropathic PainNeuralgiaPostherpetic NeuralgiaNCT01264237Analgesic Solutions120
Unknown
4 期
Study Assessing the Efficacy of Etoricoxib in Female Patients With FibromyalgiaFibromyalgiaNCT00755521Meir Medical Center80