PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders (157)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT00922428
First received: June 16, 2009
Last updated: April 16, 2015
Last verified: April 2015
  Purpose
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.

Condition
Rheumatic Diseases
Arthralgia
Myalgias/Myopathy
Lumbago

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders: A Non-interventional Observational Study.

Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) [ Time Frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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) ] [ Designated as safety issue: No ]
    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.

  • Pain in Movement [ Time Frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.

  • Morning Stiffness [ Time Frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) ] [ Designated as safety issue: No ]
    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.

  • Tenderness [ Time Frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Acceptance of the Drug [ Time Frame: from enrollment until completion ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1389
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational group
Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort of adult patients suffering from rheumatic diseases and relating symptoms who present themselves in German Primary Care Centers.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922428

Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
Investigators
Study Director: Anja Braschoss, MD Pascoe Pharmazeutische Praeparate GmbH
  More Information

Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT00922428     History of Changes
Other Study ID Numbers: 157 A 07 PA 
Study First Received: June 16, 2009
Results First Received: May 16, 2013
Last Updated: April 16, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
rheumatism
arthralgia
myalgia
lumbago
homoeopathy
injection
PASCOE-Agil HOM Injektopas
efficacy
tolerability
acceptance
safety

Additional relevant MeSH terms:
Rheumatic Diseases
Collagen Diseases
Arthralgia
Myalgia
Low Back Pain
Musculoskeletal Diseases
Connective Tissue Diseases
Joint Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Pain
Neuromuscular Diseases
Back Pain

ClinicalTrials.gov processed this record on July 24, 2016