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

NCT02128490 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2016-11-03

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in gout participants with moderate renal impairment.

Conditions

  • Gout
  • Moderate 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

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02128490 on ClinicalTrials.gov