Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-25 @ 8:19 PM
Study NCT ID:
NCT02568735
Status:
COMPLETED
Last Update Posted:
2016-05-03
First Post:
2015-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-05-15', 'releaseDate': '2017-04-11'}, {'resetDate': '2023-01-24', 'releaseDate': '2022-12-29'}, {'resetDate': '2023-04-06', 'releaseDate': '2023-03-14'}], 'estimatedResultsFirstSubmitDate': '2017-04-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118296', 'term': 'dexketoprofen trometamol'}, {'id': 'D000077613', 'term': 'Etoricoxib'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-30', 'studyFirstSubmitDate': '2015-10-05', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebrospinal fluid concentration dexketoprofen and etoricoxib', 'timeFrame': '0-24 hours', 'description': 'Cerebrospinal fluid concentration of dexketoprofen and etoricoxib'}, {'measure': 'Plasma concentration dexketoprofen and etoricoxib', 'timeFrame': '0-24 hours', 'description': 'Plasma concentration dexketoprofen and etoricoxib'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '0-24 h', 'description': 'Pain assessed with numeral rating scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexketoprofen', 'Etoricoxib', 'hip arthroplasty', 'pain'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study was to determine the plasma and central nervious system pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their efficacy in postoperative pain treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* agreed to participate the study\n* American Society of Anesthesiologist s physical status classification 1-3\n* elective hip arthroplasty planned\n* no contraindications to the study drugs\n* no contraindication to lumbar puncture\n\nExclusion Criteria:\n\n* refused to participate the study\n* age less than 40 or over 75 years\n* Planned anesthesia method other than spinal anesthesia\n* contraindications to the study drugs\n* Contraindications to lumbar puncture'}, 'identificationModule': {'nctId': 'NCT02568735', 'acronym': 'etoketo', 'briefTitle': 'Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'The Central Nervous Penetration of Dexketoprofen and Etoricoxib and Their Effect on Pain and Inflammatory Reaction in Patients Undergoing Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'KUH30062008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etoricoxib', 'description': 'Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight\\> 90kg by mouth', 'interventionNames': ['Drug: Etoricoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexketoprofen', 'description': 'Dexketoprofen 0,5 mg/kg up to 50 mg intravenously', 'interventionNames': ['Drug: Dexketoprofen']}], 'interventions': [{'name': 'Dexketoprofen', 'type': 'DRUG', 'description': 'After total hip replacement surgery patient were given either etoricoxib or dexketoprofen', 'armGroupLabels': ['Dexketoprofen']}, {'name': 'Etoricoxib', 'type': 'DRUG', 'description': 'After total hip replacement surgery patient were given either etoricoxib or dexketoprofen', 'armGroupLabels': ['Etoricoxib']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Merja Kokki', 'investigatorAffiliation': 'Kuopio University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-04-11', 'type': 'RELEASE'}, {'date': '2017-05-15', 'type': 'RESET'}, {'date': '2022-12-29', 'type': 'RELEASE'}, {'date': '2023-01-24', 'type': 'RESET'}, {'date': '2023-03-14', 'type': 'RELEASE'}, {'date': '2023-04-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Merja Kokki, MD, PhD, Kuopio University Hospital'}}}}