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Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
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: Takeda

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Takeda

Summary

The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).

Secondary outcome:

Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28

Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit

Percent Change From Baseline in Serum Urate Levels at Week 28.

Percent Change From Baseline in Serum Urate Levels at Final Visit

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.

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.

Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.

Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit

Percentage 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 (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

Locations and Contacts

Additional Information

Uloric Package Insert

FDA Safety Alerts and Recalls

Starting date: February 2003
Last updated: January 31, 2012

Page last updated: August 23, 2015

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