NCT00757627已完成4 期
Patient-reported Outcomes With Etoricoxib in Real Life
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 主要终点
- The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4
研究概览
简要总结
The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must Be Over 20 Years Of Age, Regardless Of Sex
- •Must Have A Diagnosis Of OA That Requiring Treatment
- •Patients Must Have Taken an NSAID, Cox-2 Or Opioids On The Majority Of Days During The Last 4 Weeks Before Enrollment Who Are Intolerant (Due To Gastrointestinal Adverse Events) Or Inadequately Respond To Current Therapy (Vas >= 40 mm On A Pain Scale From 0-100 mm)
- •Excluding Osteoarthritis, The Patient Is Judged To Be In Otherwise General Good Health Based On Medical History, Physical Examination, And Routine Laboratory Tests
- •Must Agree To Participate Voluntarily In The Study
- •Must Have The Capacity To Understand And Answer The Questionnaires Used In The Study
- •Must Agree To Return For A Follow-Up Visit With The Treating Physician Four Weeks After The Initiation Of Treatment With Etoricoxib
- •Patient Is Willing To Sign Informed Consent Form
排除标准
- •Under 20 Years Of Age
- •Severe Hepatic Insufficiency (Child-Pugh Score > 9)
- •Advanced Renal Insufficiency (Creatinine Clearance < 30 Ml/Min)
- •Any Contraindication Or Warning Or Precaution As Mentioned In The Approved Study Drug Package Insert
- •Gi Ulcer With Active Bleeding Present At Study Enrollment
- •Patient Has A Recent History Of Stroke, Myocardial Infarction Or Transient Ischemic Attack (Within The Previous 2 Years)
研究组 & 干预措施
1
Experimental
Etoricoxib
干预措施: etoricoxib (Drug)
结局指标
主要结局
The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4
时间窗: Baseline and end of week 4
WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain")
次要结局
- Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)(Baseline)
- Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4(Baseline and Week 4)
- Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4(Baseline and Week 4)
- Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4(Baseline and Week 4)
- Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4(Baseline and Week 4)
- Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline(Baseline)
- Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART(Week 4)
- Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4(Week 4)
- Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4(Baseline and Week 4)
研究者
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