CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,790 enrolled
Drug / intervention
Febuxostat IR +5 moredrug
Likely dose
Not stated in 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/NCT02139046
NCT02139046Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double Blind, Multicenter, Placebo Controlled Study to Evaluate the Efficacy and Safety of Febuxostat 40 mg XR, 80 mg XR, 40 mg IR and 80 mg IR in Subjects With Gout

Takeda·interventional·Posted May 15, 2014·Updated Nov 3, 2016

In Brief

A Phase 3 clinical trial evaluating Febuxostat IR, Febuxostat XR, and 4 other interventions for Gout. Completed, enrolled 1,790 participants across 192 sites.

Detailed 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 participants with gout.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 15, 2014
Enrollment StartApr 1, 2014
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.1 years ago

Interventions

Febuxostat IRdrug

Febuxostat IR over-encapsulated tablets

Febuxostat XRdrug

Febuxostat XR over-encapsulated capsules

Febuxostat placebodrug

Febuxostat placebo-matching capsules

Colchicinedrug

Colchicine tablets

Naproxendrug

Naproxen tablets

Lansoprazoledrug

Lansoprazole capsules