CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled
Drug / intervention
Febuxostat +2 moredrug
Likely dose
Febuxostat 40 mg, 80 mg, or 120 mg orally once daily, dose-adjusted based on serum urate levelAI-extracted
Key inclusion· 5
  • ✓Serum uric acid ≥8.0 mg/dL at entry to parent study TMX-00-004
  • ✓Meet American College of Rheumatology (ACR) criteria for gout diagnosis
  • ✓Serum creatinine <1.5 mg/dL (adequate renal function)
  • ✓Completed 4 weeks of double-blind dosing in parent study TMX-00-004
Key exclusion· 5
  • ✕History of xanthinuria
  • ✕Alcohol consumption >14 drinks per week
  • ✕History of significant concomitant illness
  • ✕Active liver disease

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

Search/NCT00174941
NCT00174941Phase 2Completed
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Phase II, Open-Label Study, to Assess the Long-Term Safety of Oral TMX-67 in Subjects With Gout

Takeda·interventional·Posted Sep 15, 2005·Updated Jan 27, 2011

In Brief

A Phase 2 clinical trial evaluating Febuxostat for Gout. Completed, enrolled 116 participants.

Detailed Summary

The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartMar 1, 2001
Primary CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.8 years ago

Interventions

Febuxostatdrug

Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.

Febuxostatdrug

Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.

Febuxostatdrug

Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.