Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT00995618
Status:
COMPLETED
Last Update Posted:
2011-01-06
First Post:
2009-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C012293', 'term': 'tranilast'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-05', 'studyFirstSubmitDate': '2009-10-06', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2011-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean decrease in serum uric acid levels', 'timeFrame': 'Seven days'}], 'secondaryOutcomes': [{'measure': 'Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gout', 'Hyperuricemia'], 'conditions': ['Gout', 'Hyperuricemia']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and PD as measured by reduction in serum uric acid levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18 to 70\n* Subjects with hyperuricemia who are otherwise healthy\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* Known history of gout\n* Clinically significant infection at Screening\n* Known sensitivity to tranilast or febuxostat'}, 'identificationModule': {'nctId': 'NCT00995618', 'briefTitle': 'Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nuon Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Febuxostat Compared With Tranilast Alone and Febuxostat Alone in Healthy Subjects With Hyperuricemia', 'orgStudyIdInfo': {'id': 'A3006GT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranilast', 'description': 'Tranilast tablets', 'interventionNames': ['Drug: Tranilast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Febuxostat', 'description': 'Febuxostat tablets', 'interventionNames': ['Drug: Febuxostat']}, {'type': 'EXPERIMENTAL', 'label': 'Combination', 'description': 'Tranilast plus febuxostat', 'interventionNames': ['Drug: Combination - Tranilast and Febuxostat']}], 'interventions': [{'name': 'Tranilast', 'type': 'DRUG', 'description': 'Tranilast tablets, 300 mg, QD', 'armGroupLabels': ['Tranilast']}, {'name': 'Febuxostat', 'type': 'DRUG', 'otherNames': ['Uloric'], 'description': 'Febuxostat Tablets, 40 mg, QD', 'armGroupLabels': ['Febuxostat']}, {'name': 'Combination - Tranilast and Febuxostat', 'type': 'DRUG', 'description': 'Tranilast, 300 mg QD; Febuxostat, 40 mg QD', 'armGroupLabels': ['Combination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Nuon Investigative Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Nuon Investigative Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Nuon Investigative Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Director, Nuon Clinical Trials Group', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nuon Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nuon Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Nuon Therapeutics Clinical Trials Contact', 'oldOrganization': 'Nuon Therapeutics'}}}}