A Phase 3, Randomized, Double Blind, Multicenter, Placebo Controlled Study to Evaluate the Efficacy and Safety of Febuxostat 40 mg XR, 80 mg XR, 40 mg IR and 80 mg IR in Subjects With Gout

NCT02139046 Phase 3 COMPLETED Results posted

The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in participants with gout.

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	1790
Start date	2014-04
Completion	2015-11

Conditions

• Gout

Interventions

• Febuxostat IR
• Febuxostat XR
• Febuxostat placebo
• Colchicine
• Naproxen
• Lansoprazole

Primary outcomes

• Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3 — Month 3

Countries

United States