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CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat

NCT02579096 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 950

Last updated 2024-03-29

Study results available
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Summary

This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum uric acid and therefore prevent further gout attacks. These therapies have never been compared at appropriate doses. Further, they will be studied in patients with kidney disease for the first time.

Conditions

  • Gout
  • Chronic Kidney Diseases

Interventions

DRUG

allopurinol capsule, 100-800 mg by mouth once daily

Patients will be up-titrated up to the dose required to reach target uric acid levels.

DRUG

febuxostat tablet 40-120 mg by mouth once daily

Patients will be up-titrated to the dose required to reach target uric acid levels.

DRUG

Placebo, vehicle control (febuxostat-shaped)

Placebo tablets resembling febuxostat will be given with allopurinol.

DRUG

Placebo, vehicle control (allopurinol-shaped)

Placebo capsules resembling allopurinol will be given with febuxostat.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • James R O'Dell · Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2021-02-01
Completion
2021-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02579096 on ClinicalTrials.gov