Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-14 @ 6:00 AM
Study NCT ID:
NCT04244695
Status:
UNKNOWN
Last Update Posted:
2020-01-28
First Post:
2020-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Steroid in Controlling Pain After TKA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-24', 'studyFirstSubmitDate': '2020-01-24', 'studyFirstSubmitQcDate': '2020-01-24', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain level', 'timeFrame': '12, 24 ,36, 48, 60 and 72 hours after surgery', 'description': 'VAS for pain (0-100) at rest and on motion'}], 'secondaryOutcomes': [{'measure': 'nausea and vomiting', 'timeFrame': 'in the first 72 hours after surgery', 'description': 'rate of nausea and vomiting'}, {'measure': 'Range of motion of the knee', 'timeFrame': '24, 72 hours then 2, 6, 12 weeks after surgery', 'description': 'Flexion and extension angle'}, {'measure': 'Functional outcome', 'timeFrame': '2, 6,12 weeks after surgery', 'description': 'Modified WOMAC score'}, {'measure': 'Blood sugar', 'timeFrame': 'At 8.00 am of 1, 2, 3 days after surgery', 'description': 'Fasting blood sugar level'}, {'measure': 'inflammatory level', 'timeFrame': 'At 8.00 am of 1, 2, 3 days and 2 weeks after surgery', 'description': 'C-reactive protein level'}, {'measure': 'Wound complications', 'timeFrame': '3 months after surgery', 'description': 'Deep and superficial wound infection, wound dehiscense'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral corticosteroid', 'postoperative pain', 'dexamethasone', 'total knee arthroplasty'], 'conditions': ['Pain, Acute']}, 'descriptionModule': {'briefSummary': 'To compare efficacy of oral steroid in controlling pain after TKA', 'detailedDescription': 'To compare pain and functional outcome for oral dexamethasone 16 mg, 8 mg and pacebo in patient undergoing unilateral primary total knee arthroplasy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with osteoarthritis of the knee who undergoing unilateral TKA\n* ASA class I-III\n* Informed consent\n* Good cognitive function\n\nExclusion Criteria:\n\n* Uncontrolled DM (HbA1C \\> 7)\n* Uncontrolled HT\n* Morbid obesity (BMI \\> 40)\n* History of bleeding in GI tract\n* Corticosteroid used within 6 months\n* Sever liver or renal impairments\n* Studied drug allergy'}, 'identificationModule': {'nctId': 'NCT04244695', 'briefTitle': 'Oral Steroid in Controlling Pain After TKA', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'Efficacy of Oral Corticosteroid in Controlling Pain After Total Knee Arthroplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OrthoTU11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone 16 mg', 'description': 'Dexamethasone (4mg) 4 tab oral once daily in the morning', 'interventionNames': ['Drug: Dexamethasone Oral']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone 8 mg', 'description': 'Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning', 'interventionNames': ['Drug: Dexamethasone Oral']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 4 tab oral once daily in the morning', 'interventionNames': ['Drug: Dexamethasone Oral']}], 'interventions': [{'name': 'Dexamethasone Oral', 'type': 'DRUG', 'description': 'To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA', 'armGroupLabels': ['Dexamethasone 16 mg', 'Dexamethasone 8 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066', 'city': 'Khlong Luang', 'state': 'Changwat Pathum Thani', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'supakit kanitnate', 'role': 'CONTACT', 'email': 'naypeng@hotmail.com', 'phone': '6629260000'}, {'name': 'Nattapol Tammachote, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Supakit Kanitnate, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'department of orthopaedic surgery, Faculty of medicine, Thammasat university', 'geoPoint': {'lat': 14.06467, 'lon': 100.64578}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'membership', 'investigatorFullName': 'Supakit Kanitnate', 'investigatorAffiliation': 'Thammasat University'}}}}