Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout

Phase 3 Completed 1790 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2014-04
Primary completion: 2015-11
Completion: 2015-11

Publications

Saag KG, Becker MA, Whelton A, Hunt B, Castillo M, Kisfalvi K, Gunawardhana L. Efficacy and Safety of Febuxostat Extended and Immediate Release in Patients With Gout and Renal Impairment: A Phase III Placebo-Controlled Study. Arthritis Rheumatol. 2019 Jan;71(1):143-153. doi: 10.1002/art.40685.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Febuxostat IR	Unknown	40 mg	Oral
Comparator	Febuxostat IR	Unknown	80 mg	Oral
Subject	Febuxostat XR	Unknown	40 mg	Oral
Subject	Febuxostat XR	Unknown	80 mg	Oral
Background	Colchicine	Small molecule	0.6 mg	Oral
Background	Lansoprazole	Other / unclassified	15 mg	Oral
Background	Naproxen	Small molecule	250 mg	Oral

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout

Summary

Timeline

Publications

Drugs

Indications