Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-29 @ 1:03 AM
Study NCT ID:
NCT01311804
Status:
UNKNOWN
Last Update Posted:
2011-03-10
First Post:
2011-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of Periarticular Parecoxib Sodium for Pain Management in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C409945', 'term': 'parecoxib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-08', 'studyFirstSubmitDate': '2011-03-03', 'studyFirstSubmitQcDate': '2011-03-08', 'lastUpdatePostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain control', 'timeFrame': '4 days', 'description': 'Post operative pain control( Visual Analogue Scale) with 0 corresponding to "no pain" and 10 to" the worst imaginable pain". Pain will be measured 1st 6 hours, 12 hours, 24 hours and daily for 4 days.'}], 'secondaryOutcomes': [{'measure': 'Number and duration of adverse events', 'timeFrame': '4 days', 'description': '* Morphine consumption\n* Metochlopromide usage during the 4 days\n* Lactulose usage during the 4 days\n* Range of motion measured by physiotherapist at 24 hours and daily for 4 days\n* time to single leg raise\n* time to ambulation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Unilateral Primary Osteoarthritis of Knee']}, 'descriptionModule': {'briefSummary': 'Primary Research Objective:\n\nThe primary objective of this study is to determine efficacy of periarticular parecoxib sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management in total knee arthroplasty\n\nSecondary Research Objective:\n\n* To determine if perioperative use of parecoxib sodium was associated with improved clinical outcomes\n* To evaluate the safety, in terms of adverse events; serious adverse events and tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail', 'detailedDescription': 'This is a multi-center, open label, parallel randomized trial designed to evaluate the efficacy and safety of periarticular parecoxib sodium compared to intravenous parecoxib sodium.\n\n125 patients with primary knee osteoarthritis from 4 participating sites who meet inclusion/exclusion criteria will be enrolled into the trial. After initial screening, patients will attend clinic for baseline examination. Subjects will then randomly allocated to periarticular parecoxib sodium or intravenous sodium in ratio of 1:1. patients are observed at post-operative 6, 12, 24 hours, subsequently daily for 4 days and finally at 2 week follow-up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary knee osteoarthritis on treatment and planned for unilateral total knee arthroplasty and on spinal/general anesthesia\n* Subjects age more than 50 and less than 85 years\n* Patients with body weight at least 50 kg and not more than 50%above ideal body weight\n* Written informed consent obtained from patient or guardian\n\nExclusion Criteria:\n\n* Female patients who are attempting to conceive/pregnant\n* Known allergy or hypersensitivity to cocktail regime or to COX-2 inhibitors\n* History of bleeding disorders or coagulation defect\n* Patients with abnormal liver profile\n* Patients with history of stroke or major neurological defect\n* Patients with neuropathic pain/sensory disorder\n* Patients with peptic ulceration or anticoagulant use within 1 month\n* History of previous major knee surgery/trauma\n* Patients with renal insufficiency\n* History of revision total knee arthroplasty\n* Patients with knee deformity \\> 20 degrees\n* Patients planned for bilateral knee arthroplasty during the same setting\n* Patients with significant bone loss requiring augmentation\n* Patients with history of using NSAIDs 24 hours before the surgery'}, 'identificationModule': {'nctId': 'NCT01311804', 'briefTitle': 'An Efficacy and Safety Study of Periarticular Parecoxib Sodium for Pain Management in Total Knee Arthroplasty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Malaysia'}, 'officialTitle': 'An Open Label,Multicentre, Randomized Trial to Determine the Efficacy of Periarticular Parecoxib Sodium In A Multimodal Cocktail vs Intravenous Parecoxib Sodium for Pain Management in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '02-2010'}, 'secondaryIdInfos': [{'id': 'Ministry of Health', 'type': 'OTHER_GRANT', 'domain': 'MOH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'periarticular parecoxib sodium', 'description': 'patients will be given periarticular parecoxib sodium injection', 'interventionNames': ['Procedure: parecoxib sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intravenous parecoxib sodium', 'description': 'intravenous parecoxib sodium will be given during total knee arthroplasty', 'interventionNames': ['Procedure: parecoxib sodium']}], 'interventions': [{'name': 'parecoxib sodium', 'type': 'PROCEDURE', 'otherNames': ['dynastat'], 'description': 'periarticular parecoxib sodium injection will be given during total knee arthroplasty', 'armGroupLabels': ['periarticular parecoxib sodium']}, {'name': 'parecoxib sodium', 'type': 'PROCEDURE', 'otherNames': ['dynastat'], 'description': 'intravenous parecoxib sodium during total knee arthroplasty', 'armGroupLabels': ['intravenous parecoxib sodium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01000', 'city': 'Kangar', 'state': 'Perlis', 'country': 'Malaysia', 'contacts': [{'name': 'Yeap Ewe Juan', 'role': 'CONTACT', 'phone': '+604-976 3333'}, {'name': 'Yeap Ewe Juan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Tuanku Fauziah', 'geoPoint': {'lat': 6.4414, 'lon': 100.19862}}], 'centralContacts': [{'name': 'Shanthini Govindasamy', 'role': 'CONTACT', 'email': 'shanthini@crc.gov.my', 'phone': '+603-26924249'}], 'overallOfficials': [{'name': 'Yeap Ewe Juan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOH Malaysia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, Malaysia', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Yeap Ewe Juan', 'oldOrganization': 'Name/Official Title: Dr. Yeap Ewe Juan'}}}}