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Biochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in GOUT
ISRCTN ISRCTN21473387
DOI 10.1186/ISRCTN21473387
ClinicalTrials.gov identifier
EudraCT number
Public title Biochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in GOUT
Scientific title
Acronym GOUT-1
Serial number at source N/A
Study hypothesis 1. Allopurinol has a poor efficacy and tolerability profile to lower serum urate to target levels less than 0.30 mmol/l
2. Benzbromarone is more potent and is better tolerated than probenecid to lower serum urate to target levels less than 0.30 mmol/l
Lay summary
Ethics approval Ethics approval received by the Medical Centre Leeuwarden on the 7th February 2005 (ref: TPO-357).
Study design Randomised, active controlled, parallel group, multicentre trial
Countries of recruitment Netherlands
Disease/condition/study domain Hyperuricemia, gout
Participants - inclusion criteria 1. Aged greater than 18 years
2. Diagnosis gout based on crystal evidence or American Rheumatism Association (ARA) criteria
3. Eestimated creatinine clearance more than 50 ml/min
4. Baseline values measured: serum urate, urinary urate excretion, serum creatinine
Participants - exclusion criteria 1. Contra-indication for allopurinol, benzbromaron or probenecid
2. Prior treatment with allopurinol, benzbromaron or probenecid
Anticipated start date 01/06/2005
Anticipated end date 31/05/2007
Status of trial Completed
Patient information material
Target number of participants 96
Interventions Stage 1: allopurinol 1dd 300 mg (eight weeks)
Stage 2:
1. Benzbromarone 1dd 200 mg (eight weeks), or
2. Probenecide 2dd 1000 mg (eight weeks)
Primary outcome measure(s) Success rate on study medication consisting of patient tolerability and attainment of target level serum urate less than 0.30 mmol/l after eight weeks treatment.
Secondary outcome measure(s) 1. Serum urate lowering effect (% decrease) of the antihyperuricemic agent
2. Tolerability of the antihyperuricemic agent (adverse drug reactions)
Sources of funding Medical Centre Leeuwarden (The Netherlands)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18250112
Contact name Dr  M K  Reinders
  Address Medical Centre Leeuwarden
Department of Clinical Pharmacy and Pharmacology
P.O. Box 888
  City/town Leeuwarden
  Zip/Postcode 8901 BR
  Country Netherlands
  Tel +31 (0)58 286 6610
  Fax +31 (0)58 286 6606
  Email m.reinders@znb.nl
Sponsor Medical Centre Leeuwarden (The Netherlands)
  Address Department of Clinical Pharmacy and Pharmacology
P.O. Box 888
  City/town Leeuwarden
  Zip/Postcode 8901 BR
  Country Netherlands
Date applied 26/02/2007
Last edited 08/02/2008
Date ISRCTN assigned 26/02/2007
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