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

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 gout participants with moderate renal impairment.

Timeline

Start

2014-05

Primary completion

2015-09

Completion

2015-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Febuxostat XR 40 mg; p <0.001; Difference in Proportions 35.9 (95% CI 20.8 to 51.0); Fisher Exact NCT02128490 ↗

paper At month 3, all febuxostat treatment groups were associated with greater proportions of patients achieving sUA < 5.0 mg/dl (p < 0.05 vs placebo). PMID 29848361 ↗

Publications

• Gunawardhana L, Becker MA, Whelton A, Hunt B, Castillo M, Saag K. Efficacy and safety of febuxostat extended release and immediate release in patients with gout and moderate renal impairment: phase II placebo-controlled study. Arthritis Res Ther. 2018 May 30;20(1):99. doi: 10.1186/s13075-018-1593-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Febuxostat	Small molecule	40 mg	Oral
Comparator	Febuxostat	Small molecule	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

Indications