Efficacy and Safety of Oral Febuxostat in Participants With Gout (CONFIRMS)

Takeda

Status and phase: Completed; Phase 3

Conditions: Gout

Treatments: Drug: Allopurinol; Drug: Febuxostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430248

U1111-1114-0226 (Registry Identifier)

F-GT06-153

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.

Full description

Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Treatment duration will be 6 months.

Enrollment: 2,269 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).

Exclusion criteria

• Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
• Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
• History of xanthinuria.
• Alcohol consumption greater than 14/week.
• History of significant concomitant illness.
• Active liver or peptic ulcer disease.
• Has rheumatoid arthritis requiring treatment.
• Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
• Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,269 participants in 3 patient groups

Febuxostat 40 mg QD

Experimental group

Treatment:

Drug: Febuxostat

Drug: Febuxostat

Febuxostat 80 mg QD

Experimental group

Treatment:

Drug: Febuxostat

Drug: Febuxostat

Allopurinol 200 mg or 300 mg QD

Active Comparator group

Description:

(dependent on renal function)

Treatment:

Drug: Allopurinol