Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study

Study Overview
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Brief Summary
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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.

Detailed Description
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This retrospective analysis of physician prescribing data (long-term concessional cohort from the Medicare Australia PBS claims dataset for the time period 2008-2011 (4 years) will compare the use of extended release paracetamol (Panadol Osteo) with standard paracetamol 500mg in a cohort of Australian concessional patients with OA, to assess differences in prescribing patterns and patient compliance.

Official Title
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Panadol Osteo PBS Claims Cohort Study

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Paracetamol 665 mg
* Drug: Paracetamol 500 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Extended Release Paracetamol<br>Participants prescribed with extended release paracetamol tablet containing 665 mg paracetamol. | Drug: Paracetamol 665 mg<br>* Paracetamol 665 mg tablet<br>* Other names: Panadol Osteo;|
| Standard Paracetamol<br>Participants prescribed with standard paracetamol tablet containing 500 mg paracetamol. | Drug: Paracetamol 500 mg<br>* Paracetamol 500 mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative number of prescriptions of an extended release paracetamol formulation and a standard release paracetamol formulation. | Number of episodes of treatment for OA with the extended release formulation and the standard release formulatins will be counted. | January 2009 to December 2010 | 
| Relative treatment compliance with an extended release paracetamol formulation and a standard release paracetamol formulation | Interval between the repeat doses of extended release paracetamol formulation and the standard release paracetamol formulation. | January 2009 to December 2010 |