Clinical trial NCT00922428: PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders
Official title: PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders: A Non-interventional Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatic Diseases
Arthralgia
Myalgias/Myopathy
Lumbago
Keywords: rheumatism
arthralgia
myalgia
lumbago
homoeopathy
injection
PASCOE-Agil HOM Injektopas
efficacy
tolerability
acceptance
safety
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 1389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
measure: Tolerability of the Drug
timeFrame: after end of study
measure: Pain at Rest
timeFrame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
measure: Pain in Movement
timeFrame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
measure: Pain After Rest
timeFrame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
measure: Pain on Weight-bearing
timeFrame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
measure: Morning Stiffness
timeFrame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
measure: Tenderness
timeFrame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
measure: Antalgic Position
timeFrame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Secondary outcomes:
measure: Acceptance of the Drug
timeFrame: from enrollment until completion
Other outcomes:
Locations:
Study officials:
affiliation: Pascoe Pharmazeutische Praeparate GmbH
name: Anja Braschoss, MD
role: STUDY_DIRECTOR
References: