Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-07 @ 9:22 PM
Study NCT ID:
NCT00620867
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2008-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)
Sponsor:
Organization:
Raw JSON
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{'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 393}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2008-02-12', 'studyFirstSubmitQcDate': '2008-02-12', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS)", 'timeFrame': 'Week 6'}], 'secondaryOutcomes': [{'measure': 'Vital signs', 'timeFrame': 'Weeks 2 and 6'}, {'measure': 'Physical examination', 'timeFrame': 'Week 6'}, {'measure': 'Laboratory test results', 'timeFrame': 'Week 6'}, {'measure': 'Adverse events', 'timeFrame': 'Weeks 2 and 6'}, {'measure': "Change from baseline in patient's and physician's global assessment of pain", 'timeFrame': 'Weeks 2 and 6'}, {'measure': 'Pain Satisfaction Scale', 'timeFrame': 'Days 1-7'}, {'measure': 'Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index', 'timeFrame': 'Week 6'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Week 6'}, {'measure': "Change from baseline in patient's assessment of arthritis pain according to VAS", 'timeFrame': 'Week 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191063&StudyName=Efficacy%20and%20Safety%20of%20Celecoxib%20versus%20Ibuprofen%20in%20the%20Treatment%20of%20Osteoarthritis%20of%20the%20Knee%20%28United%20States%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\>= 40 years old\n* Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit\n* Functional capacity class of I-III\n\nExclusion Criteria:\n\n* Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)\n* Acute joint trauma at index joint within the past 3 months with active symptoms\n* Score of \\>=20 on PHQ-9 or score of \\>=1 on PHQ-9 item i\n* Use of mobility assisting device for \\<6 weeks or use of walker'}, 'identificationModule': {'nctId': 'NCT00620867', 'briefTitle': 'Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'A3191063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibuprofen', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'EXPERIMENTAL', 'label': 'Celecoxib', 'interventionNames': ['Drug: celecoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Ibuprofen', 'type': 'DRUG', 'description': '800 mg oral tablet three time daily with meals for 6 weeks', 'armGroupLabels': ['Ibuprofen']}, {'name': 'celecoxib', 'type': 'DRUG', 'description': '200 mg oral capsule once daily with morning meal for 6 weeks', 'armGroupLabels': ['Celecoxib']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'matched placebo orally for 6 weeks', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 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