PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders

Rheumatic Diseases Clinical Trial

— 157  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922428
• Other study ID #: 157 A 07 PA
• Status: Completed
• Phase: N/A
• First received: June 16, 2009
• Last updated: April 16, 2015
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: April 2015
• Source: Pascoe Pharmazeutische Praeparate GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1389
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthralgia
• Lumbago
• Myalgia
• Myalgias/Myopathy
• Rheumatic Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pascoe Pharmazeutische Praeparate GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)	No
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: very well tolerated (no side effects); moderately tolerated (mild side effects); poorly tolerated (marked side effects)	after end of study	Yes
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.	Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)	No
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.	Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)	No
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.	Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)	No
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.	Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)	No
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.	Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)	No
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.	Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)	No
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.	Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)	No
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.	from enrollment until completion	Yes