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

NCT00922428 | Completed Results

• 1 other identifier: 157 A 07 PA
• Study Type: observational
• Target: 1,389
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatic Diseases; Arthralgia; Myalgias/Myopathy; Lumbago

Keywords

rheumatism; arthralgia; myalgia; lumbago; homoeopathy; injection; PASCOE-Agil HOM Injektopas; efficacy; tolerability; acceptance; safety

Outcome Measures

Primary Outcomes (9)

• 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)

• 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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (1)

• Acceptance of the Drug

  from enrollment until completion

Study Arms (1)

Observational group

Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead

MeSH Terms

Conditions

Rheumatic Diseases; Arthralgia; Myalgia; Muscular Diseases; Low Back Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Back Pain

Results Point of Contact

• Title: Anja Braschoss
• Organization: Pascoe pharmazeutische Präparate GmbH

KlinischeForschung@pascoe.de

0049 641 7960100

Study Officials

• Anja Braschoss, MD

  Pascoe Pharmazeutische Praeparate GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 4, 2015
• Results First Posted: May 4, 2015

Record last verified: 2015-04