RDEA594 in combination with Allopurinol in subjects with gout: V1

• Research type

  Research Study

• Full title

  Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients with an Inadequate Hypouricemic Response with standard Doses of Allopurinol

• IRAS ID

  32518

• Contact name

  John Calvert

• Sponsor organisation

  Ardea Biosciences, Inc

• Eudract number

  2009-014660-19

• ISRCTN Number

  n/a

• Research summary

  A large number of patients who take allopurinol to treat gout may still have increased levels or uric acid in their blood. This may cause further gout attacks. This study aims to establish whether or not RDEA594 when taken in combination with allopurinol reduces a patient blood urate further. The study will also assess how well tolerated the combination of treatments is.The study will recruit gout patients who are being treated with 300mg of allopurinol whose serum urate is over 6 mg/dL. Patients will attend for up to 12 visits over an eight week period and be required to take RDEA for 4 weeks and another drug colchicine for 6 weeks. Colchicine is given to reduce the likelihood of gout attacks. 3 doses of RDEA594 will be tested (between 100 and 400 mg). The changes in blood uric acid will be compared patient who receive a dummy medication. Patients will have a 1 in 3 chance of receiving this dummy medication.The study will be conducted in 1 GP surgery and 1 specialist trial centre in England.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/113

• Date of REC Opinion

  9 Dec 2009

• REC opinion

  Further Information Favourable Opinion