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Completed

NCT Number: NCT00922428

PASCOE-Agil HOM-Injektopas in the 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.

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Key information

Conditions

Rheumatic Diseases Arthralgia Back Pain Connective Tissue Diseases Joint Diseases Low Back Pain Lumbago Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Myalgias/Myopathy Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):

  • Males and females
  • At least 18 years old
  • Rheumatic disease with accompanying symptoms, e.g. arthralgia, myalgia, lumbago etc.

Exclusion criteria

for documentation:

  • younger than 18 years
  • no Rheumatic disease with accompanying symptoms, e.g. arthralgia, myalgia, lumbago etc.
  • no treatment with PASCOE-Agil HOM-Injektopas

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Acceptance of the Drug

    Time frame: from enrollment until completion

    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.

Sponsors and collaborators

Lead sponsor

Pascoe Pharmazeutische Praeparate GmbH

Industry

Registry information

Official study title

PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders: A Non-interventional Observational Study.

Acronym: 157

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2009
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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