Clinical trial NCT00174915: Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
Official title: A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Keywords: Uric Acid, gout, xanthine oxidase, febuxostat, tophi
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 1072
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.

Detailed description: A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.

Subjects will receive treatment for 28 weeks.

Eligibility criteria: Inclusion Criteria:

* Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
* Renal function defined as a serum creatinine level of \< 2.0 mg/dL and creatinine clearance of \> 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion Criteria:

* History of xanthinuria
* Intolerance to allopurinol
* Presence of renal calculi,
* Alcohol intake of ≥ 14 drinks/week
* Clinically significant medical condition

Primary outcomes:
measure: Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).
timeFrame: Last 3 visits (any last 3 visits up to week 28)
Secondary outcomes:
measure: Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28
timeFrame: Week 28
measure: Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit
timeFrame: Final Visit (up to 28 weeks).
measure: Percent Change From Baseline in Serum Urate Levels at Week 28.
timeFrame: Baseline and Week 28
measure: Percent Change From Baseline in Serum Urate Levels at Final Visit
timeFrame: Baseline and Final Visit (up to 28 weeks)
measure: Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.
timeFrame: Baseline and Week 28
measure: Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.
timeFrame: Baseline and Final Visit (up to 28 weeks)
measure: Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.
timeFrame: Baseline and Week 28
measure: Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit
timeFrame: Final Visit (up to 28 weeks)
measure: Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.
timeFrame: Weeks 8 through 28
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Schumacher HR Jr, Becker MA, Wortmann RL, Macdonald PA, Hunt B, Streit J, Lademacher C, Joseph-Ridge N. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008 Nov 15;59(11):1540-8. doi: 10.1002/art.24209.
citation: Becker MA, MacDonald PA, Hunt BJ, Lademacher C, Joseph-Ridge N. Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy. Nucleosides Nucleotides Nucleic Acids. 2008 Jun;27(6):585-91. doi: 10.1080/15257770802136032.
citation: Wortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008.
citation: Chohan S, Becker MA, MacDonald PA, Chefo S, Jackson RL. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680.