Phase III Trial of Febuxostat in Korea Gout Patients

Gout Clinical Trial

Official title:

A Randomized, Multi-Center, Double Blinded, Allopurinol-Controlled, Placebo-Controlled Parallel Group, 5-Arm, Dose-Response,Bridging Study to Assess the Efficacy and Safety of Febuxostat in Subject With Gout

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821392
• Other study ID #: TMX-67
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2009
• Last updated: January 12, 2009
• Start date: August 2006
• Est. completion date: September 2007

Study information

• Verified date: October 2007
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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>

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Febuxostat

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.