OsteoarthritisNCT02262702
Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study
An observational study of Osteoarthritis, run by GlaxoSmithKline.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Paracetamol 665 mg and Paracetamol 500 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of Australian concessional patients with osteoarthritis
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Paracetamol 665 mg, Paracetamol 500 mg
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol 665 mgDrug
Also called Panadol Osteo
Paracetamol 665 mg tablet
Paracetamol 500 mgDrug
Paracetamol 500 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Extended Release Paracetamol | Participants prescribed with extended release paracetamol tablet containing 665 mg paracetamol. Receives: Drug: Paracetamol 665 mg | |
| Standard Paracetamol | Participants prescribed with standard paracetamol tablet containing 500 mg paracetamol. Receives: Drug: Paracetamol 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: January 2009 to December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262702
- Sponsor's protocol ID
- 202175
- Other IDs
- RH01690
- Status last verified
- Jan 2016
- First submitted
- 23 May 2013
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panadol Osteo PBS Claims Cohort Study
- ClinicalTrials.gov ID
- NCT02262702
- Acronym / sponsor ID
- 202175
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Release Paracetamol | – | Drug: Paracetamol 665 mgParticipants prescribed with extended release paracetamol tablet containing 665 mg paracetamol. |
| Standard Paracetamol | – | Drug: Paracetamol 500 mgParticipants prescribed with standard paracetamol tablet containing 500 mg paracetamol. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of Australian concessional patients with osteoarthritis
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol 665 mgAlso: Panadol OsteoParacetamol 665 mg tablet | Drug | Extended Release Paracetamol |
| Paracetamol 500 mgParacetamol 500 mg tablet | Drug | Standard Paracetamol |
Primary outcome
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative number of prescriptions of an extended release paracetamol formulation and a standard release paracetamol formulation. (time frame: January 2009 to December 2010). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.