NCT00042068已完成3 期
A Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 234
- 主要终点
- Response according to American College of Rheumatology 20% (ACR20) classification
研究概览
简要总结
A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 and less than or equal to 80
- •Diagnosis of Rheumatoid Arthritis for at least six weeks
- •Taking an NSAID
- •If female: using adequate contraception
- •Willingness to stop current NSAID until criteria reached to begin study drug
- •Able to provide written informed consent
排除标准
- •Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug
- •Pregnancy, lactating
- •Use of investigational drug within 30 days prior to entering the trial
- •History of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding
- •History of cerebrovascular or other bleeding disorder
- •Severe hypertension
- •Other disease that might interfere with safety of the patient or evaluation of trial drug (investigator's opinion)
- •RA of functional class IV
- •Synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial
- •Concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic GI-medication, analgesic drug (except acetaminophen up to 4 grams/day)
- •DMARDs initiated within past three months or dose changed less than two months before entering the trial
- •Therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial
- •Concomitant therapy with ACTH within past month before entering the trial.
- •History of narcotic or alcohol abuse (past 12 months)
- •Abnormal laboratory values
- •Previous participation in the present trial
结局指标
主要结局
Response according to American College of Rheumatology 20% (ACR20) classification
时间窗: at 12 weeks
次要结局
- Investigator's final global (overall) assessment of efficacy(at end of 12 weeks)
- Patient status with regard to change in arthritic condition(at end of 12 weeks)
- Number of painful or tender joints(up to 12 weeks)
- Number of swollen joints(up to 12 weeks)
- Patient's global (overall) assessment of disease activity(up to 12 weeks)
- Investigator's global (overall) assessment of disease activity(up to 12 weeks)
- Patient's assessment of pain(up to 12 weeks)
- Patient's assessment of physical function (mHAQ)(up to 12 weeks)
- Withdrawal due to lack of efficacy(up to 12 weeks)
- Use of rescue medication(up to 12 weeks)
- Patient's final global assessment of tolerability(at end of 12 weeks)
- Investigator's final global assessment of tolerability(at end of 12 weeks)
- C-Reactive Protein (CRP)(up to 12 weeks)
- Duration of morning stiffness(up to of 12 weeks)
- Patient's final global (overall) assessment of efficacy(at end of 12 weeks)
- Incidence and intensity of adverse events(until 4 weeks post treatment)
- Withdrawals due to adverse events(at end of 12 weeks)
研究者
研究点 (234)
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