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

NCT00174915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1072

Last updated 2012-02-02

Study results available
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Summary

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

Conditions

Interventions

DRUG

Febuxostat

Febuxostat 80 mg, orally, once daily for up to 28 weeks.

DRUG

Febuxostat

Febuxostat 120 mg, orally, once daily for up to 28 weeks.

DRUG

Febuxostat

Febuxostat 240 mg, orally, once daily for up to 28 weeks.

DRUG

Allopurinol

Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine \>1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.

DRUG

Placebo

Placebo, orally, once daily for up to 28 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
2003-02-28
Primary Completion
2004-04-30
Completion
2004-04-30

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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 NCT00174915 on ClinicalTrials.gov