Phase 2 Gout Dose Response Study

• Research type

  Research Study

• Full title

  Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients with Gout

• IRAS ID

  27797

• Eudract number

  2009-013055-30

• ISRCTN Number

  n/a

• Research summary

  The purpose of this study is to assess the safety and efficacy of RDEA594 in establishing sUA concentrations in gout subjects with hyperuricemia defined as a sUA level of = 8.0 mg/dl. Subjects will be randomized in a 3:1 ratio to one of the following 3 dose regimens of RDEA594 or RDEA594 matching placebo:* Treatment Group 1: RDEA594 200 mg once daily qd for 28 days* Treatment Group 2: RDEA594 200 mg qd for 7 days followed by 400 mg qd for 21 days* Treatment Group 3: RDEA594 200 mg qd for 7 days followed by 400 mg qd for7 days followed by 600 mg qd for 14 days* Treatment Group 4: RDEA594 matching placebo qd for 28 daysTo reduce the incidence of gout flares and nephrolithiasis, the dose will be titrated (blinded) in the mid- and high dose treatment groups. Subjects will be evaluated weekly during the Treatment Period, and will return for an End of Study visit approximately 2 weeks after the final dose of study medication for measurement of sUA levels and safety assessments.Subjects currently taking urate lowering therapy (ULT) will be required to wash-out for at least 14 days before Baseline (Day 0).To reduce the incidence of gout flares, a total daily dose of colchicine 1.0-1.2 mg will be administered to all subjects beginning 14 days prior to Baseline (Day 0). Subjects will continue the use of colchicine throughout the Treatment Period, and will discontinue the use of colchicine at the End of Study visit (2 weeks after the last dose of study medication). Subjects who experience a gout flare during the screening period can be rescreened after the gout flare has resolved for at least one week.Subjects who meet the entry criteria will be randomized 7 days prior to Day 0 in a double-blind fashion to receive RDEA594 or RDEA594 matching placebo.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/94

• Date of REC Opinion

  24 Sep 2009

• REC opinion

  Further Information Favourable Opinion