Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 3

Conditions: Gout

Treatments: Drug: Allopurinol; Drug: Febuxostat

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02082769

SFDA2010L04287

Details and patient eligibility

About

The purpose of this study is to compare febuxostat allopurinol in subjects with gout.

Full description

A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects will receive treatment for 24 weeks.

Enrollment: 504 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese 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 Cockcroft and Gault formula;
• No gout flare 2 weeks beforehand during 2-week screening period.

Exclusion criteria

• 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 active liver disease, or hepatic dysfunction;
• A history of bronchial asthma;
• A history of renal calculi or thyroid disease;
• Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor;
• Intolerance to allopurinol and Ibuprofen;
• Alcohol intake of ≥ 14 drinks/week;
• Clinically significant medical condition.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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504 participants in 3 patient groups

Febuxostat 40 mg QD

Experimental group

Description:

Febuxostat 40 mg, orally, once daily for up to 24 weeks

Treatment:

Drug: Febuxostat

Febuxostat 80 mg QD

Experimental group

Description:

Febuxostat 80 mg, orally, once daily for up to 24 weeks

Treatment:

Drug: Febuxostat

Allopurinol 100mg QD

Active Comparator group

Description:

Allopurinol 100mg, orally, three times daily for up to 24 weeks

Treatment:

Drug: Allopurinol