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MBX-102 (Arhalofenate) + Allopurinol in Gout
NCT01399008Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2011
- Primary completion
- Feb 2012
- Countries
- 3
- Sponsor
- Gilead Sciences
- Modality
- Small Molecules
- Drugs
- arhalofenate
- Conditions
- gout
01
Overview
Phase 2, randomised, double-blind trial of arhalofenate in gout (3 arms), sponsored by Gilead Sciences. Primary endpoint: Percent change from baseline in serum uric acid at 4 weeks. Started Jun 2011; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Arhalofenate 400 mg
Arhalofenate 400 mg + Allopurinol 300 mg + Colchicine
Arhalofenate 600 mg
Arhalofenate 600 mg + Allopurinol 300 mg + Colchicine
Allopurinol Control
Placebo + Allopurinol 300 mg + Colchicine
03
Who it enrols
Gout patients aged 18-75 with inadequate hypouricemic response to allopurinol alone (sUA >= 6.5 mg/dL on >= 200 mg/day allopurinol, or sUA >= 8.0 mg/dL if on < 200 mg/day or no ULT).
04
Endpoints
Primary
Percent change from baseline in serum uric acid
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