CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 153 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Febuxostat 40–120 mg orally once daily for up to 4 weeksAI-extracted
Key inclusion· 3
  • ✓Serum uric acid ≥8.0 mg/dL
  • ✓Meet American College of Rheumatology criteria for gout
  • ✓Adequate renal function (serum creatinine <1.5 mg/dL)
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/NCT00174967
NCT00174967Phase 2Completed
CompareCT.gov

Phase II, Dose-Response, Safety and Efficacy Study of Oral TMX-67 in Subjects With Gout.

Takeda·interventional·Posted Sep 15, 2005·Updated Jul 29, 2011

In Brief

A Phase 2 clinical trial evaluating Placebo and Febuxostat for Gout. Completed, enrolled 153 participants.

Detailed Summary

The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate 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 StartJan 1, 2001
Primary CompletionJul 1, 2001
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 20.8 years ago

Interventions

Placebodrug

Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.

Febuxostatdrug

Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.

Febuxostatdrug

Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.

Febuxostatdrug

Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.