Phase III Trial of Febuxostat in Korea Gout Patients

NCT ID: NCT00821392

Last Updated: 2009-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-09-30

Brief Summary

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

Detailed Description

This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration.

If 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.

Conditions

Gout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1 Febuxostat 40mg

Group Type: ACTIVE_COMPARATOR

Febuxostat

Intervention Type: DRUG

2 Febuxostat 80mg

Group Type: ACTIVE_COMPARATOR

Febuxostat

Intervention Type: DRUG

3 Febuxostat 120mg

Group Type: ACTIVE_COMPARATOR

Febuxostat

Intervention Type: DRUG

4 Allopurinol 300mg

Group Type: SHAM_COMPARATOR

Febuxostat

Intervention Type: DRUG

5 Placebo

Group Type: PLACEBO_COMPARATOR

Febuxostat

Intervention Type: DRUG

Interventions

Febuxostat

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

<Day -14>

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 <Day -1>

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

SK Chemicals Co.,Ltd.

Other Identifiers

TMX-67

Identifier Type: -

Identifier Source: org_study_id