Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study
Panadol Osteo PBS Claims Cohort Study
2 other identifiers
observational
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 23, 2013
CompletedFirst Posted
Study publicly available on registry
October 13, 2014
CompletedJanuary 25, 2016
January 1, 2016
Same day
May 23, 2013
January 21, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Extended Release Paracetamol
Participants prescribed with extended release paracetamol tablet containing 665 mg paracetamol.
Standard Paracetamol
Participants prescribed with standard paracetamol tablet containing 500 mg paracetamol.
Interventions
Paracetamol 665 mg tablet
Eligibility Criteria
Cohort of Australian concessional patients with osteoarthritis
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2013
First Posted
October 13, 2014
Study Start
January 1, 2013
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
January 25, 2016
Record last verified: 2016-01