Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-04-25 @ 2:50 AM
Study NCT ID:
NCT02262702
Status:
WITHDRAWN
Last Update Posted:
2016-01-25
First Post:
2013-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-21', 'studyFirstSubmitDate': '2013-05-23', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative number of prescriptions of an extended release paracetamol formulation and a standard release paracetamol formulation.', 'timeFrame': 'January 2009 to December 2010', 'description': 'Number of episodes of treatment for OA with the extended release formulation and the standard release formulatins will be counted.'}, {'measure': 'Relative treatment compliance with an extended release paracetamol formulation and a standard release paracetamol formulation', 'timeFrame': 'January 2009 to December 2010', 'description': 'Interval between the repeat doses of extended release paracetamol formulation and the standard release paracetamol formulation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort of Australian concessional patients with osteoarthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants prescribed with a paracetamol product and categorized as a concessional patient\n* 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)\n\nExclusion Criteria:\n\n* Participants with Rheumatoid arthritis or other auto-immune inflammatory conditions\n* Participants receiving the following anti-rheumatoid therapies:Immunimodulators such as methotrexate, leflunamide and TNF blockers\n* Participants receiving treatment for cancer pain'}, 'identificationModule': {'nctId': 'NCT02262702', 'briefTitle': 'Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Panadol Osteo PBS Claims Cohort Study', 'orgStudyIdInfo': {'id': '202175'}, 'secondaryIdInfos': [{'id': 'RH01690', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Extended Release Paracetamol', 'description': 'Participants prescribed with extended release paracetamol tablet containing 665 mg paracetamol.', 'interventionNames': ['Drug: Paracetamol 665 mg']}, {'label': 'Standard Paracetamol', 'description': 'Participants prescribed with standard paracetamol tablet containing 500 mg paracetamol.', 'interventionNames': ['Drug: Paracetamol 500 mg']}], 'interventions': [{'name': 'Paracetamol 665 mg', 'type': 'DRUG', 'otherNames': ['Panadol Osteo'], 'description': 'Paracetamol 665 mg tablet', 'armGroupLabels': ['Extended Release Paracetamol']}, {'name': 'Paracetamol 500 mg', 'type': 'DRUG', 'description': 'Paracetamol 500 mg tablet', 'armGroupLabels': ['Standard Paracetamol']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}