Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-30 @ 9:59 AM
Study NCT ID:
NCT00359151
Status:
TERMINATED
Last Update Posted:
2021-03-03
First Post:
2006-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celebrex Total Knee Arthroplasty Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'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': 22}}, 'statusModule': {'whyStopped': 'This study was terminated early due to slow enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2006-07-28', 'studyFirstSubmitQcDate': '2006-07-28', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effects of celecoxib on the cumulative amount of opioid administered to OA subjects undergoing unilateral total knee arthroplasty.', 'timeFrame': '19 July 2007'}], 'secondaryOutcomes': [{'measure': 'To assess the effects of celecoxib on pain and function during the peri-operative period and the post-operative rehabilitation phase.', 'timeFrame': '19 July 2007'}, {'measure': 'To assess the safety and tolerability of celecoxib in this study population.', 'timeFrame': '19 July 2007'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Perioperative care of total arthroplasty assessing opioid consumption'], 'conditions': ['Osteoarthritis', 'Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191225&StudyName=Celebrex%20Total%20Knee%20Arthroplasty%20Study', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the benefits of administering celecoxib (Celebrex), a selective cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the management of post total knee replacement pain, and through the 6 weeks of physical therapy and rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject is a male or female 18 years or older with osteoarthritis of the knee scheduled to undergo elective unilateral primary total knee arthroplasty because of OA, performed under a standardized regimen of anesthesia and procedure.\n\nExclusion Criteria:\n\n* Subject has a history of inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis) other than osteoarthritis.'}, 'identificationModule': {'nctId': 'NCT00359151', 'briefTitle': 'Celebrex Total Knee Arthroplasty Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Multicenter, Double Blind, Randomized, Placebo Controlled Trial Of The Efficacy And Safety Of Usual Care Plus Celecoxib Compared To Placebo For Peri-Operative And Rehabilitation Pain Control And Return To Function In Osteoarthritis Patients Undergoing Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'A3191225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celecoxib', 'description': 'Celecoxib', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'description': '7 days pre-surgery (excluding day of surgery): 1 celecoxib 200 mg capsule or matching placebo QD; Day of surgery: 2 celecoxib 200 mg capsules or matching placebo within 2 hours prior to surgery, and 1 celecoxib 200 mg capsule or matching placebo following surgery; Post-surgery: starting the day after surgery, 1 celecoxib 200 mg capsule or matching placebo BID for the duration of the study.', 'armGroupLabels': ['Celecoxib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily (QD) for 7 days pre-surgery (excluding the day of surgery); Placebo within 2 hours prior to surgery; and post surgery on the same day of the surgery; Placebo twice daily (BID) following the day of surgery and for the duration of the study.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80110', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77410', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}