Conditions: Gout
Keywords: Hyperuricemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in combination with allopurinol compared to allopurinol alone when administered orally once a day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol alone.

Detailed description:

Arms:
arm 1: Arhalofenate 400 mg plus allopurinol 300 mg arm 2: Arhalofenate 600 mg plus allopurinol 300 mg arm 3: Placebo plus Allopurinol 300 mg

Interventions: intervention 1: Arhalofenate intervention 2: Allopurinol intervention 3: Colchicine intervention 4: Placebo
Intervention descriptions: intervention 1: Arhalofenate 400 and 600 mgs over-encapsulated tablets once daily for 4 weeks or Allopurinol 300 mg once daily for 4 weeks intervention 2: Allopurinol 300 mg as active comparator intervention 3: 0.6 mg colchicine daily as flare prophylaxis intervention 4: Placebo

Protocol document: