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NCT02139046 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
1,790
Enrollment target

NCT02139046: Completed Phase 3 study, sponsored by Takeda.

NCT02139046 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 1,790 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02139046, a Phase 3 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
1,790 participants
Enrollment target

Study 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.

Interventions

  • DRUG Colchicine
  • DRUG Naproxen
  • DRUG Febuxostat placebo
  • DRUG Febuxostat IR
  • DRUG Febuxostat XR

Trial Details

FieldValue
Enrollment Target 1,790 participants
Start Date 2014-04
Est. Completion 2015-11
Phase Phase 3
Takeda

408 total trials

What the finished NCT02139046 record still lists

NCT02139046 is an interventional study that assigns participants to a tested intervention. Its 1,790 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (132% higher).

The record links to 0 conditions, and to 5 interventions - of which Colchicine is the first listed.

NCT02139046 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02139046 about?

NCT02139046 is a clinical study titled "Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout". 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.

What is the current status of trial NCT02139046?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,790 participants. The study started on 2014-04. Estimated completion is 2015-11.

What interventions are being tested in trial NCT02139046?

The interventions under investigation include: Colchicine (DRUG), Naproxen (DRUG), Febuxostat placebo (DRUG), Febuxostat IR (DRUG), Febuxostat XR (DRUG).

Who is sponsoring clinical trial NCT02139046?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02139046's enrollment target sits among peer trials

1,790 125th of 2000 higher than 1,876 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02139046, the US trial registry maintained by the National Library of Medicine. NCT02139046 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.