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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational group | Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | 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. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
| Tolerability of the Drug | 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:
| after end of study |
| Pain at Rest | 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. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
| Pain in Movement | 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. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
| Pain After Rest | 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. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of the Drug | Number of patients with good (patient was satisfied with the treatment, there was nothing to complain about) or poor (patient was not satisfied with the treatment, there were ADRs or other reasons) acceptance. | from enrollment until completion |
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Due to the design as an Observational Study no inclusion or exclusion criteria for therapy are named. The included patient group is described under "Cohort / Group".
Observational Criteria (=inclusion criteria for documentation):
Exclusion criteria for documentation:
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Cohort of adult patients suffering from rheumatic diseases and relating symptoms who present themselves in German Primary Care Centers.
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| Name | Affiliation | Role |
|---|---|---|
| Anja Braschoss, MD | Pascoe Pharmazeutische Praeparate GmbH | Study Director |
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The observational study was carried out between January 2008 and the end of May 2008 by 280 therapists. The non-interventional character of an observational study meant that no exact timeframe for the treatment of patients was specified.
The observational study was carried out by medically-trained doctors who generally treated patients with rheumatic disorders. By choosing a range of different medical specialties - predominantly orthopaedics, rheumatology, general medicine, sports medicine and family doctors - it was ensured that a broad spectrum of patients was recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational Group | Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Group | Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) | 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. | due to character of an observational study: all patient who had a value, descriptive | Posted | Mean | Standard Deviation | units on a scale | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
|
between January 2008 and the end of May 2008
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational Group | Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anja Braschoss | Pascoe pharmazeutische Präparate GmbH | 0049 641 7960100 | KlinischeForschung@pascoe.de |
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| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| D018771 | Arthralgia |
| D063806 | Myalgia |
| D009135 | Muscular Diseases |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
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| Pain on Weight-bearing | 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. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
| Morning Stiffness | 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. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
| Tenderness | 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. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
| Antalgic Position | 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. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | gender of the patients | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Observational Group (Visit 3) |
VAS of the observational group at visit 3 |
|
|
| Primary | Tolerability of the Drug | 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:
| 1374 were full analysed, data of 2 patient were additionally analysed for tolerability | Posted | Number | percentage of participants | after end of study |
|
|
|
| Secondary | Acceptance of the Drug | Number of patients with good (patient was satisfied with the treatment, there was nothing to complain about) or poor (patient was not satisfied with the treatment, there were ADRs or other reasons) acceptance. | due to the character of an observational study: descriptive | Posted | Number | percentage of participants | from enrollment until completion |
|
|
|
| Primary | Pain at Rest | 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. | due to character of an observational study: descriptive, all patients who had an value | Posted | Number | percentage of participants | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
|
|
|
| Primary | Pain in Movement | 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. | due to character of an observational study: descriptive, all patients who had an value | Posted | Number | percentage of participants | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
|
|
|
| Primary | Pain After Rest | 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. | due to character of an observational study: descriptive, all patients who had an value | Posted | Number | percentage of participants | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
|
|
|
| Primary | Pain on Weight-bearing | 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. | due to character of an observational study: descriptive, all patients who had an value | Posted | Number | percentage of participants | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
|
|
|
| Primary | Morning Stiffness | 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. | due to character of an observational study: descriptive, all patients who had an value | Posted | Number | percentage of participants | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
|
|
|
| Primary | Tenderness | 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. | due to character of an observational study: descriptive, all patients who had an value | Posted | Number | percentage of participants | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
|
|
|
| Primary | Antalgic Position | 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. | due to character of an observational study: descriptive, all patients who had an value | Posted | Number | percentage of participants | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) |
|
|
|
| 0 |
| 1,376 |
| 23 |
| 1,376 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
| D001416 | Back Pain |