Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-27 @ 5:29 PM
Study NCT ID:
NCT00821392
Status:
COMPLETED
Last Update Posted:
2009-01-13
First Post:
2009-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Trial of Febuxostat in Korea Gout Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069465', 'term': 'Febuxostat'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-12', 'studyFirstSubmitDate': '2009-01-12', 'studyFirstSubmitQcDate': '2009-01-12', 'lastUpdatePostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Gout']}, 'descriptionModule': {'briefSummary': 'This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea', 'detailedDescription': 'This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration.\n\nIf subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\<Day -14\\>\n\n1. age :18-85 years\n2. female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception\n3. female: negative serum pregnancy test\n4. subjects who satisfy ARA (American Rheumatism Association)\n5. subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL \\<Day -1\\>\n\n1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria\n\nExclusion Criteria:\n\n1. women who are breast-feeding or pregnant\n2. a history of xanthinuria\n3. allopurinol intolerance\n4. receiving thiazide diuretic therapy\n5. secondary hyperuricemia\n6. required \\> 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed.\n7. concomitant therapy containing aspirin or other salicylates(systemic or topical, prescribed or non-prescribed) stable, low doses aspirin will be allowed(i.e. ≤325mg/day).\n8. any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit\n9. alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited.\n10. concomitant therapy with any urate-lowering therapy\n11. active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN\n12. subject was unable to take colchicine or contradictory to colchicine\n13. a serum urate level \\< 8.0mg/dL and not taking uric acid lowering therapy\n14. rheumatoid arthritis or any active arthritis requiring for the medication treatment\n15. a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the screening visit, or had taken any systemic cancer chemotherapy within 5 years prior to the screening visit\n16. participated in another investigational trial within the 30days prior to the screening visit\n17. any other significant medical condition as defined by the investigator'}, 'identificationModule': {'nctId': 'NCT00821392', 'briefTitle': 'Phase III Trial of Febuxostat in Korea Gout Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'A Randomized, Multi-Center, Double Blinded, Allopurinol-Controlled, Placebo-Controlled Parallel Group, 5-Arm, Dose-Response,Bridging Study to Assess the Efficacy and Safety of Febuxostat in Subject With Gout', 'orgStudyIdInfo': {'id': 'TMX-67'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 Febuxostat 40mg', 'interventionNames': ['Drug: Febuxostat']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Febuxostat 80mg', 'interventionNames': ['Drug: Febuxostat']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 Febuxostat 120mg', 'interventionNames': ['Drug: Febuxostat']}, {'type': 'SHAM_COMPARATOR', 'label': '4 Allopurinol 300mg', 'interventionNames': ['Drug: Febuxostat']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5 Placebo', 'interventionNames': ['Drug: Febuxostat']}], 'interventions': [{'name': 'Febuxostat', 'type': 'DRUG', 'armGroupLabels': ['1 Febuxostat 40mg', '2 Febuxostat 80mg', '3 Febuxostat 120mg', '4 Allopurinol 300mg', '5 Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'SK Chemicals Co.,Ltd.', 'oldOrganization': 'SK Chemicals Co.,Ltd.'}}}}