Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study

Osteoarthritis Clinical Trial

Official title:

Panadol Osteo PBS Claims Cohort Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02262702
• Other study ID #: 202175
• Secondary ID: RH01690
• Status: Withdrawn
• Phase: N/A
• First received: May 23, 2013
• Last updated: January 21, 2016
• Start date: January 2013
• Est. completion date: January 2013

Study information

• Verified date: January 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Paracetamol 665 mg
Paracetamol 665 mg tablet
• Paracetamol 500 mg
Paracetamol 500 mg tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No