Conditions: Gout
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 607
Healthy volunteers: no

Brief summary:
This study that compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.

Detailed description:
Allopurinol is the standard of care for the treatment of gout. Nevertheless, most patients treated with allopurinol do not achieve the recommended serum urate (sUA) target of \< 6.0 mg/dL and need additional therapy to achieve the target. Probenecid and benzbromarone are uric acid transporter 1 (URAT1) inhibitors, generally recommended as second-line agents for patients who are either resistant to or intolerant of allopurinol. However, benzbromarone is not available in the US and probenecid is rarely used. Consequently, there is a clear unmet medical need for a new safe and effective therapy for gout, such as lesinurad, a potent URAT1 inhibitor, that can be used in combination with allopurinol in patients not responding adequately to allopurinol monotherapy so that very high rates of response can be achieved by nearly all gout patients, rather than a minority.The subjects selected for this study will have moderate to severe gout with an inadequate response to allopurinol

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Lesinurad intervention 2: Lesinurad intervention 3: Placebo intervention 4: Allopurinol intervention 5: Allopurinol intervention 6: Allopurinol
Intervention descriptions: intervention 1: Tablets, 200 mg once daily (qd) intervention 2: Tablets, 400 mg qd intervention 3: Tablets, Placebo qd intervention 4: Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment) intervention 5: Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment) intervention 6: Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)

Protocol document: