Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT01177267
Status:
COMPLETED
Last Update Posted:
2012-05-01
First Post:
2010-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions(DDI) Among Osteoarthritis Patients
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'count': 10000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-28', 'studyFirstSubmitDate': '2010-08-05', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['retrospective database analysis in osteoarthritis patients'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Using a retrospective database analysis, OA patients taking at least one CYP450-metabolized opioid (codeine, fentanyl, hydrocodone, methadone, oxycodone, or tramadol) and at least one other prescription drug metabolized via the CYP450 system were evaluated for an incident drug-drug exposure (DDE), which places them at risk for experiencing a pharmacokinetic drug-drug interaction (DDI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'retrospective database analysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* osteoarthritis\n\nExclusion Criteria:\n\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01177267', 'briefTitle': 'Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions(DDI) Among Osteoarthritis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'NEMA Research, Inc.'}, 'officialTitle': 'Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Osteoarthritis Patients Taking Opioid Analgesics and Associated Economic Outcomes', 'orgStudyIdInfo': {'id': 'CYP450OA3'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joseph Pergolizzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NEMA Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NEMA Research, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joseph Pergolizzi, MD', 'investigatorAffiliation': 'NEMA Research, Inc.'}}}}