Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study

January 21, 2016 updated by: GlaxoSmithKline

Panadol Osteo PBS Claims Cohort Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cohort of Australian concessional patients with osteoarthritis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Extended Release Paracetamol
Participants prescribed with extended release paracetamol tablet containing 665 mg paracetamol.
Drug: Paracetamol 665 mg
Paracetamol 665 mg tablet
Other Names:
  • Panadol Osteo
Standard Paracetamol
Participants prescribed with standard paracetamol tablet containing 500 mg paracetamol.
Drug: Paracetamol 500 mg
Paracetamol 500 mg tablet

What is the study measuring?

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.
Time Frame: 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.
January 2009 to December 2010
Relative treatment compliance with an extended release paracetamol formulation and a standard release paracetamol formulation
Time Frame: January 2009 to December 2010
Interval between the repeat doses of extended release paracetamol formulation and the standard release paracetamol formulation.
January 2009 to December 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202175
  • RH01690 (Other Identifier: GSK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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