Phase III Trial of Febuxostat in Korea Gout Patients

NCT00821392 | Completed Phase 3

• 1 other identifier: TMX-67
• Study Type: interventional
• Target: 181
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea

Conditions

Gout

Study Arms (5)

1 Febuxostat 40mg

ACTIVE COMPARATOR

Drug: Febuxostat

2 Febuxostat 80mg

ACTIVE COMPARATOR

Drug: Febuxostat

3 Febuxostat 120mg

ACTIVE COMPARATOR

Drug: Febuxostat

4 Allopurinol 300mg

SHAM COMPARATOR

Drug: Febuxostat

5 Placebo

PLACEBO COMPARATOR

Drug: Febuxostat

Interventions

Febuxostat DRUG

1 Febuxostat 40mg; 2 Febuxostat 80mg; 3 Febuxostat 120mg; 4 Allopurinol 300mg; 5 Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<Day -14\>
• age :18-85 years
• female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception
• female: negative serum pregnancy test
• subjects who satisfy ARA (American Rheumatism Association)
• subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL \<Day -1\>

You may not qualify if:

• women who are breast-feeding or pregnant
• a history of xanthinuria
• allopurinol intolerance
• receiving thiazide diuretic therapy
• secondary hyperuricemia
• required \> 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed.
• 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).
• any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit
• alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited.
• concomitant therapy with any urate-lowering therapy
• active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN
• subject was unable to take colchicine or contradictory to colchicine
• a serum urate level \< 8.0mg/dL and not taking uric acid lowering therapy
• rheumatoid arthritis or any active arthritis requiring for the medication treatment
• 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

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

MeSH Terms

Conditions

Gout

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 13, 2009
• Study Start: August 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: January 13, 2009

Record last verified: 2007-10