Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
Information source: TAP Pharmaceutical Products Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gout
Intervention: Febuxostat (Drug); Febuxostat (Drug); Febuxostat (Drug); Allopurinol (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: TAP Pharmaceutical Products Inc. Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: TAP Pharmaceutical Products Inc.
Summary
A Study comparing febuxostat, allopurinol and placebo in subjects with gout.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The proportion of subjects whose last three serum urate levels are < 6.0 mg/dL.
Secondary outcome: The proportion of subjects whose serum urate levels are <6.0 mg/dL;The percent reduction in serum urate levels; The percent reduction in primary tophus size, as determined by physical measurement in the subset of subjects with palpable tophi at the Screening Visit.; The reduction in the total number of tophi in the subset of subjects with palpable tophi at the Screening Visit; The proportion of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the Double-Blind Treatment Period.
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
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hyperuricemia (sUA ≥8. 0mg/dL) and gout by ARA Criteria
- Renal function defined as a serum creatinine level of < 2. 0 mg/dL and creatinine
clearance of > 20 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
Locations and Contacts
Additional Information
Starting date: February 2003
Ending date: April 2004
Last updated: June 13, 2008
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