Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT00333567
Status:
COMPLETED
Last Update Posted:
2007-12-13
First Post:
2006-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C473384', 'term': 'lumiracoxib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'lastUpdateSubmitDate': '2007-12-12', 'studyFirstSubmitDate': '2006-06-01', 'studyFirstSubmitQcDate': '2006-06-01', 'lastUpdatePostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity (PI) in the target knee after movement at the 2 h time-point'}], 'secondaryOutcomes': [{'measure': 'PI at 1, 2, 3, 4 and 24 h time-points while at rest'}, {'measure': 'PI at 1, 3, 4 and 24 h time-points after movement'}, {'measure': 'Time to first rescue medication intake'}, {'measure': "Patient's global evaluation of response to study medication"}, {'measure': 'Safety and tolerability profile'}]}, 'conditionsModule': {'keywords': ['arthroscopic knee surgery', 'cyclooxygenase-2 inhibitors', 'lumiracoxib', 'COX189', 'Ambulatory arthroscopic knee surgery'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the efficacy and safety of a single daily dose of 400 mg lumiracoxib given pre-emptively versus post-operatively in terms of efficacy in reducing pain associated with ambulatory arthroscopic knee surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who need scheduled minor ambulatory arthroscopic knee surgery.\n\nExclusion Criteria:\n\n* Patients with any surgical or medical conditions which could place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00333567', 'briefTitle': 'Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Compare Efficacy of a Single Dose of Lumiracoxib 400 mg Given Pre-Emptively Versus Post-Operatively, in Reducing Pain Associated With Ambulatory Arthroscopic Knee Surgery', 'orgStudyIdInfo': {'id': 'CCOX189A2427'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lumiracoxib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Novartis', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Novartis Pharma AG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}