deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT00430248

Efficacy and Safety of Oral Febuxostat in Participants With Gout (CONFIRMS)

A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.

Sponsor: Takeda

Conditions Gout
Interventions Allopurinol Febuxostat
Updated 8 times since 2017 Last updated: Jan 31, 2012 Started: Feb 28, 2007 Primary completion: Mar 31, 2008 Completion: Mar 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Gout and is currently completed. Takeda leads this study, which shows 8 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects. Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout. Treatment duration will be 6 months.

Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Treatment duration will be 6 months.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Present [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 3 earlier versions

  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Feb 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Takeda
Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Amarillo, United States , Anaheim, United States , Ann Arbor, United States , Arlington Heights, United States , Atlanta, United States , Austin, United States , Austintown, United States , Aventura, United States , Baltimore, United States and 243 more locations