Phase III Trial of Febuxostat in Korea Gout Patients

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.
• Treatments: Allopurinol; Febuxostat

Criteria

Inclusion Criteria:

1. age :18-85 years

2. female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception

3. female: negative serum pregnancy test

4. subjects who satisfy ARA (American Rheumatism Association)

5. subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL

1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria

Exclusion Criteria:

1. women who are breast-feeding or pregnant

2. a history of xanthinuria

3. allopurinol intolerance

4. receiving thiazide diuretic therapy

5. secondary hyperuricemia

6. required > 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed.

7. 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).

8. any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit

9. alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited.

10. concomitant therapy with any urate-lowering therapy

11. active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN

12. subject was unable to take colchicine or contradictory to colchicine

13. a serum urate level < 8.0mg/dL and not taking uric acid lowering therapy

14. rheumatoid arthritis or any active arthritis requiring for the medication treatment

15. 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

16. participated in another investigational trial within the 30days prior to the screening visit

17. any other significant medical condition as defined by the investigator