Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects. (APEX)

Takeda

Status and phase: Completed; Phase 3

Conditions: Gout

Treatments: Drug: Allopurinol; Drug: Placebo; Drug: Febuxostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00174915

U1111-1113-9740 (Registry Identifier)

C02-009

Details and patient eligibility

About

The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.

Full description

A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.

Subjects will receive treatment for 28 weeks.

Enrollment: 1,072 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
• Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion criteria

• History of xanthinuria
• Intolerance to allopurinol
• Presence of renal calculi,
• Alcohol intake of ≥ 14 drinks/week
• Clinically significant medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,072 participants in 5 patient groups, including a placebo group

Febuxostat 80 mg QD

Experimental group

Treatment:

Drug: Febuxostat

Drug: Febuxostat

Drug: Febuxostat

Febuxostat 120 mg QD

Experimental group

Treatment:

Drug: Febuxostat

Drug: Febuxostat

Drug: Febuxostat

Febuxostat 240 mg QD

Experimental group

Treatment:

Drug: Febuxostat

Drug: Febuxostat

Drug: Febuxostat

Allopurinol QD

Active Comparator group

Treatment:

Drug: Allopurinol

Placebo QD

Placebo Comparator group

Treatment:

Drug: Placebo