Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study

Withdrawn

• Conditions: Osteoarthritis
• Interventions: Drug: Paracetamol 665 mg; Drug: Paracetamol 500 mg

• Registration Number: NCT02262702
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-13
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extended Release Paracetamol	Paracetamol 665 mg	Participants prescribed with extended release paracetamol tablet containing 665 mg paracetamol.
Standard Paracetamol	Paracetamol 500 mg	Participants prescribed with standard paracetamol tablet containing 500 mg paracetamol.

Primary Outcome Measures

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