CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 950 enrolled
Drug / intervention
allopurinol capsule, 100-800 mg by mouth once daily +3 moredrug
Likely dose
allopurinol capsule, 100-800 mg by mouth once dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02579096
NCT02579096Phase 4Completed
CompareCT.gov

CSP #594 - Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat

VA Office of Research and Development·interventional·Posted Oct 19, 2015·Updated Mar 29, 2024

In Brief

A Phase 4 clinical trial evaluating allopurinol capsule, 100-800 mg by mouth once daily, febuxostat tablet 40-120 mg by mouth once daily, and 2 other interventions for Gout and Chronic Kidney Diseases. Completed, enrolled 950 participants across 23 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout, Chronic Kidney Diseases
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 19, 2015
Enrollment StartMar 6, 2017
Primary CompletionFeb 1, 2021
Study CompletionApr 15, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.7 years ago

Interventions

allopurinol capsule, 100-800 mg by mouth once dailydrug

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

febuxostat tablet 40-120 mg by mouth once dailydrug

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

Placebo, vehicle control (febuxostat-shaped)drug

Placebo tablets resembling febuxostat will be given with allopurinol.

Placebo, vehicle control (allopurinol-shaped)drug

Placebo capsules resembling allopurinol will be given with febuxostat.