Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout

Phase 2 Completed 314 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint damage in patients with elevated serum urate levels and gout.

Timeline

Start: 2010-03
Primary completion: 2013-09
Completion: 2013-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Febuxostat 40 mg or 80 mg vs Placebo; p = 0.472; Ranked Analysis of Covariance (ANCOVA) NCT01078389 ↗

paper was minimal, with no between-group differences. PMID 28975718 ↗

Publications

Dalbeth N, Saag KG, Palmer WE, Choi HK, Hunt B, MacDonald PA, Thienel U, Gunawardhana L. Effects of Febuxostat in Early Gout: A Randomized, Double-Blind, Placebo-Controlled Study. Arthritis Rheumatol. 2017 Dec;69(12):2386-2395. doi: 10.1002/art.40233.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Febuxostat	Small molecule	40 mg	Oral
Subject	Febuxostat	Small molecule	80 mg	Oral

Indications

No indication recorded.