PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders: A Non-interventional Observational Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,389
- Primary Endpoint
- Tenderness
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Tenderness
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Acceptance of the Drug(from enrollment until completion)