Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-02-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Febuxostat 80 mg QD

Group Type EXPERIMENTAL

Febuxostat

Intervention Type DRUG

Febuxostat 80 mg, orally, once daily for up to 52 weeks.

Febuxostat 120 mg QD

Group Type EXPERIMENTAL

Febuxostat

Intervention Type DRUG

Febuxostat 120 mg, orally, once daily for up to 52 weeks.

Allopurinol 300 mg QD

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.

Interventions

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Febuxostat

Febuxostat 80 mg, orally, once daily for up to 52 weeks.

Intervention Type DRUG

Febuxostat

Febuxostat 120 mg, orally, once daily for up to 52 weeks.

Intervention Type DRUG

Allopurinol

Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.

Intervention Type DRUG

Other Intervention Names

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TMX-67 Tei-6720 Uloric TMX-67 Tei-6720 Uloric

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No