Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04697602
Status:
TERMINATED
Last Update Posted:
2023-11-14
First Post:
2021-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout
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': 'D003078', 'term': 'Colchicine'}, {'id': 'D000069465', 'term': 'Febuxostat'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence rate of gout flare during the first 12 weeks.', 'timeFrame': '12 weeks', 'description': 'The percentage of the patients suffered from gout flare during the first 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'The number of gout flares per patient during the first 12 weeks', 'timeFrame': '12 weeks', 'description': 'The number of gout flares per patient during the first 12 weeks'}, {'measure': 'The number of gout flares per patient during the second 12 weeks', 'timeFrame': '12 weeks', 'description': 'The number of gout flares per patient during the second 12 weeks'}, {'measure': 'The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks', 'timeFrame': '12, 24 weeks', 'description': 'The percentage of patients with serum urate \\<6.0mg/dL in 12, 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gout,febuxostat,flare prophylaxis,stepwise dose titration,colchicine'], 'conditions': ['Gout']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the incidence rate of gout flare for subjects with gout and hyperuricemia treated by two different starting doses of febuxostat.', 'detailedDescription': 'A prospective randomized open-label study comparing dose titration group (stepwise dose titration of febuxostat and low-dose colchicine) and standard treatment group (fixed dose febuxostat and low-dose colchicine) in the subjects with gout and hyperuricemia. The incidence rate of gout flare will be compared between two groups during the first 12 week of febuxostat treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Ages Eligible for Study: more than 20 years\n\nInclusion Criteria:\n\n1. Hyperuricemia (serum urate ≥7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria\n2. Acute gout attack during the last 12 months\n\nExclusion Criteria:\n\n1. Acute gout attack in the last 2 weeks\n2. Urate-lowering therapy in the last 4 weeks\n3. Secondary hyperuricemia\n4. Creatinine ≥2.0 mg/dL\n5. AST or ALT ≥2x upper limits of normal\n6. Heart failure (NYHA III-IV)\n7. Hypersensitivity to colchicine, NSAID or febuxostat\n8. Use of NSAID, glucocorticoid, cyclosporine, clarithromycin, mercaptopurine, azathioprine, pyrazinamide, ethambutol, chemotherapy, tacrolimus, losartan, and fenofibrate\n9. Inability to comply with the protocol requirements\n10. The judgement of the investigator that the patient was not an appropriate candidate'}, 'identificationModule': {'nctId': 'NCT04697602', 'briefTitle': 'Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Patients With Gout and Hyperuricemia During the Initial Phase of Urate-lowering Therapy: an Open-label Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '202009131MIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose titration group', 'description': 'Stepwise dose titration of febuxostat and low-dose colchicine', 'interventionNames': ['Drug: Stepwise dose titration of febuxostat and low-dose colchicine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment group', 'description': 'Fixed dose febuxostat and low-dose colchicine', 'interventionNames': ['Drug: Fixed dose febuxostat and low-dose colchicine']}], 'interventions': [{'name': 'Stepwise dose titration of febuxostat and low-dose colchicine', 'type': 'DRUG', 'description': 'Febuxostat 10 mg, orally, once daily, in week 1-4 Febuxostat 20 mg, orally, once daily, in week 5-8 Febuxostat 40 mg, orally, once daily, in week 9-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12', 'armGroupLabels': ['Dose titration group']}, {'name': 'Fixed dose febuxostat and low-dose colchicine', 'type': 'DRUG', 'description': 'Febuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12', 'armGroupLabels': ['Standard treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yi-Min Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital, Yun-Lin Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Taiwan University Hospital, Yun-Lin Branch', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}