Assessing the Impact of MOVALIS on Health Related Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,569
- 试验地点
- 1
- 主要终点
- Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.
研究概览
简要总结
The objective of the observational study is to examine the effect of MOVALIS (Meloxicam) therapy on Health Related Quality of Life (HRQoL) in the diverse region of Central and Eastern Europe. The Medical Outcomes Study 12 Item Short Form Health Survey version 2 (SF-12v2) will be used as the instrument to measure any change in physical wellbeing (Physical Component Summary, PCS) and mental wellbeing (Mental Component Summary, MCS) of patients following MOVALIS (Meloxicam) therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.
时间窗: baseline and final visit (approximately 4 weeks)
Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)
Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2
时间窗: Baseline and final visit (approximately 4 weeks)
Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)
次要结局
- Change From Baseline of Pain Intensity on Visual Analogue Scale(Approximately four weeks of treatment)
- Patient Assessment of Efficacy(after approximately 4 weeks of treatment)
- Physician Assessment of Efficacy(after approximately 4 weeks of treatment)