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

This study has been completed.
Sponsor:
Information provided by:
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT00922428
First received: June 16, 2009
Last updated: May 10, 2010
Last verified: May 2010
History of Changes
  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 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).


Condition
Rheumatic Disorders
Arthralgia
Myalgia
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:
  • Efficacy of the drug, measured by decrease in disease-related symptoms, (Visual Analog Scale (VAS)) [ Time Frame: Beginning, 2 + 4 weeks ] [ Designated as safety issue: No ]
  • Tolerability of the drug, measured by documentation of adverse drug reactions (ADR) [ Time Frame: from enrollment until completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acceptance of the drug by medical personnel and patients [ Time Frame: from enrollment until completion ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 are named. The included patient group is described under "Cohort / Group".

Observational Criteria:

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

No publications provided

Responsible Party: Anja Braschoss, MD, Pascoe pharmazeutische Praeparate GmbH, Clinical Research
ClinicalTrials.gov Identifier: NCT00922428     History of Changes
Other Study ID Numbers: 157 A 07 PA
Study First Received: June 16, 2009
Last Updated: May 10, 2010
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:
Arthralgia
Low Back Pain
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
 Signs and Symptoms
Back Pain
Neurologic Manifestations
Nervous System Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on June 17, 2013