Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Phase 3

Completed

• Conditions: Gout
• Interventions: Drug: Allopurinol; Drug: Febuxostat

• Registration Number: NCT02082769
• Lead Sponsor: Xijing Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-10
• Results First Submitted: 2015-05-11
• Results First Submitted QC: 2015-12-30
• Last Update Submitted: 2015-12-30
• Results First Posted: 2016-02-03
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 504

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allopurinol 100mg QD	Allopurinol	Allopurinol 100mg, orally, three times daily for up to 24 weeks
Febuxostat 40 mg QD	Febuxostat	Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat 80 mg QD	Febuxostat	Febuxostat 80 mg, orally, once daily for up to 24 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)	Last 3 visits (any last 3 visits up to week 26)

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit	Final Visit (up to 26 weeks)