Phase III Trial of Febuxostat in Korea Gout Patients

SK chemicals

Status and phase: Completed; Phase 3

Conditions: Gout

Treatments: Drug: Febuxostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00821392

TMX-67

Details and patient eligibility

About

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

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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181 participants in 5 patient groups, including a placebo group

1 Febuxostat 40mg

Active Comparator group

Treatment:

Drug: Febuxostat

2 Febuxostat 80mg

Active Comparator group

Treatment:

Drug: Febuxostat

3 Febuxostat 120mg

Active Comparator group

Treatment:

Drug: Febuxostat

4 Allopurinol 300mg

Sham Comparator group

Treatment:

Drug: Febuxostat

5 Placebo

Placebo Comparator group

Treatment:

Drug: Febuxostat