Phase III Trial of Febuxostat in Korea Gout Patients

• ClinicalTrials.gov Identifier: NCT00821392
• Recruitment Status: Completed
• First Posted: January 13, 2009
• Last Update Posted: January 13, 2009
• Sponsor: SK Chemicals Co., Ltd.
• Information provided by: SK Chemicals Co., Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Gout	Drug: Febuxostat	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 181 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: August 2006
• Actual Primary Completion Date: September 2007
• Actual Study Completion Date: September 2007

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 Febuxostat 40mg	Drug: Febuxostat
Active Comparator: 2 Febuxostat 80mg	Drug: Febuxostat
Active Comparator: 3 Febuxostat 120mg	Drug: Febuxostat
Sham Comparator: 4 Allopurinol 300mg	Drug: Febuxostat
Placebo Comparator: 5 Placebo	Drug: Febuxostat

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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>

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: SK Chemicals Co.,Ltd.
• ClinicalTrials.gov Identifier: NCT00821392
• Other Study ID Numbers: TMX-67
• First Posted: January 13, 2009
• Last Update Posted: January 13, 2009
• Last Verified: October 2007

Additional relevant MeSH terms:

Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Febuxostat; Gout Suppressants; Antirheumatic Agents