PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders: A Non-interventional Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,389
- 主要终点
- Tenderness
研究概览
简要总结
The purpose of this observational study is to give an overview of the use of PASCOE-Agil HOM-Injektopas in a 2-4 week treatment of rheumatic disorders.
详细描述
The purpose of this observational study is to give an overview of the use of PASCOE-Agil HOM-Injektopas in a 2-4 week treatment of rheumatic disorders of different aetiology and localisation, displaying a variety of symptoms.
Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management in relation to the Summary of Product Characteristics (SmPC).
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
Tenderness
时间窗: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in%) with an improvement of tenderness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Antalgic Position
时间窗: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in%) with an improvement of antalgic position V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Pain in Movement
时间窗: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in %) with an improvement of pain in movement between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Pain After Rest
时间窗: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in %) with an improvement of pain after rest between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Pain on Weight-bearing
时间窗: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in%) with an improvement of pain on weight-bearing between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Visual Analog Scale (VAS)
时间窗: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Efficacy of the drug, measured by a Visual Analog Scale (VAS) Scale ranged from 0(=best, no pain) to 10(worst, intolerable pain) The VAS was filled by the patient.
Tolerability of the Drug
时间窗: after end of study
Tolerability assessment of medical personnel End of study could by after 2 (visit 2) or after 4 weeks (Visit3). It was measured by a score: * very well tolerated (no side effects) * moderately tolerated (mild side effects) * poorly tolerated (marked side effects)
Pain at Rest
时间窗: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patient (in %) with an improvement of pain at rest between V1 and V2 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Morning Stiffness
时间窗: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in%) with an improvement of morning stiffness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
次要结局
- Acceptance of the Drug(from enrollment until completion)