Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment

PHASE2CompletedINTERVENTIONAL
Enrollment

189

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

September 30, 2015

Study Completion Date

October 31, 2015

Conditions
GoutModerate Renal Impairment
Interventions
DRUG

Febuxostat IR

Febuxostat IR over-encapsulated tablets

DRUG

Febuxostat XR

Febuxostat over-encapsulated capsules

DRUG

Febuxostat placebo

Febuxostat IR and XR placebo-matching capsules

DRUG

Colchicine

Colchicine tablets

DRUG

Naproxen

Naproxen tablets

DRUG

Lansoprazole

Lansoprazole capsules

Trial Locations (89)

32141

Riverside Clinical Research, Edgewater

38119

Remesh C Gupta MD, Memphis

40509

Central Kentucy Reseach Associates, Lexington

72223

Benny Green MD PA Family Practice, Little Rock

73103

COR Clinical Research LLC, Oklahoma City

78215

Sun Research Institute, San Antonio

78224

Briggs Clinical Research LLC, San Antonio

78413

3rd Coast Research Associates, Corpus Christi

90807

Long Beach Center for Clinical Research, Long Beach

92563

Brigid Freyne MD, Murrieta

96814

East West Medical Research Institute, Honolulu

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Sponsors

Lead Sponsor

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lead

Takeda

INDUSTRY