Last updated: 11/07/2018 12:28:27
Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Cancelled
Cancelled
Trial overview
Official title: Panadol Osteo PBS Claims Cohort Study
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Relative number of prescriptions of an extended release paracetamol formulation and a standard release paracetamol formulation.
Timeframe: January 2009 to December 2010
Relative treatment compliance with an extended release paracetamol formulation and a standard release paracetamol formulation
Timeframe: January 2009 to December 2010
Secondary outcomes:
Not applicable
Interventions:
Drug: Paracetamol 665 mg
Drug: Paracetamol 500 mg
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
RACGP Home/AFP/2016/May/Volume 45, No.5, May 2016 Pages 321-325
Medical condition
Osteoarthritis
Product
paracetamol
Collaborators
Not applicable
Study date(s)
January 2013 to January 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
50 - 85 years
Accepts healthy volunteers
No
- – 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)
- – 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
Inclusion and exclusion criteria
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
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Cancelled
Actual primary completion date
Not applicable
Actual study completion date
2013-20-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website