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Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

NCT00102440 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2012-02-02

Study results available
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Summary

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

Conditions

Interventions

DRUG

Febuxostat

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

DRUG

Febuxostat

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

DRUG

Allopurinol

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2004-02-29
Completion
2004-02-29

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00102440 on ClinicalTrials.gov