Phase III Trial of Febuxostat in Korea Gout Patients

A Randomized, Multi-Center, Double Blinded, Allopurinol-Controlled, Placebo-Controlled Parallel Group, 5-Arm, Dose-Response,Bridging Study to Assess the Efficacy and Safety of Febuxostat in Subject With Gout

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00821392

Enrollment

181

Registered

2009-01-13

Start date

2006-08-31

Completion date

2007-09-30

Last updated

2009-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Brief summary

This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea

Detailed description

This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration. If subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.

Interventions

DRUGFebuxostat

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

\<Day -14\> 1. age :18-85 years 2. female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception 3. female: negative serum pregnancy test 4. subjects who satisfy ARA (American Rheumatism Association) 5. subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL \<Day -1\> 1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026