Last updated: 11/07/2018 12:28:27

Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study

GSK study ID
202175
See study documents
Clinicaltrials.gov ID
NCT02262702
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Panadol Osteo PBS Claims Cohort Study
Trial description: The aim of this observational study is to compare the use of an extended release paracetamol formulation with standard paracetamol in a cohort of Australian concessional patients with osteoarthritis (OA), to assess differences in prescribing patterns and patient compliance.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Relative number of prescriptions of an extended release paracetamol formulation and a standard release paracetamol formulation.

Timeframe: January 2009 to December 2010

Relative treatment compliance with an extended release paracetamol formulation and a standard release paracetamol formulation

Timeframe: January 2009 to December 2010

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Paracetamol 665 mg
  • Drug: Paracetamol 500 mg
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    RACGP Home/AFP/2016/May/Volume 45, No.5, May 2016 Pages 321-325
    Medical condition
    Osteoarthritis
    Product
    paracetamol
    Collaborators
    Not applicable
    Study date(s)
    January 2013 to January 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    50 - 85 years
    Accepts healthy volunteers
    No
    • – Participants prescribed with a paracetamol product and categorized as a concessional patient
    • – Participants with new episodes of OA (no history of OA paracetamol in previous 12 months) or suffering from chronic OA (history of OA paracetamol in the previous 12 months)
    • – Participants with Rheumatoid arthritis or other auto-immune inflammatory conditions
    • – Participants receiving the following anti-rheumatoid therapies:Immunimodulators such as methotrexate, leflunamide and TNF blockers
    Inclusion and exclusion criteria
    Inclusion criteria:
    • – Participants prescribed with a paracetamol product and categorized as a concessional patient – Participants with new episodes of OA (no history of OA paracetamol in previous 12 months) or suffering from chronic OA (history of OA paracetamol in the previous 12 months)
    Exclusion criteria:
    • – Participants with Rheumatoid arthritis or other auto-immune inflammatory conditions – Participants receiving the following anti-rheumatoid therapies:Immunimodulators such as methotrexate, leflunamide and TNF blockers – Participants receiving treatment for cancer pain

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-20-01

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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