Febuxostat Versus Allopurinol Control Trial in Subjects With Gout (FACT)

Takeda

Status and phase

Completed

Phase 3

Conditions

Gout

Treatments

Drug: Febuxostat

Drug: Allopurinol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00102440

C02-010

U1111-1114-0184 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.

Full description

This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.

Enrollment

760 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

Exclusion criteria

Serum creatinine >1.5 mg/dL
Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
Pregnancy or lactation;
Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
A history of xanthinuria, active liver disease, or hepatic dysfunction;
A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.