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ISRCTN
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ISRCTN21473387
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ClinicalTrials.gov identifier
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Public title
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Biochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in GOUT
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Scientific title
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Acronym
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GOUT-1
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Serial number at source
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N/A
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Study hypothesis
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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
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Ethics approval
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Ethics approval received by the Medical Centre Leeuwarden on the 7th February 2005 (ref: TPO-357).
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Study design
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Randomised, active controlled, parallel group, multicentre trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Hyperuricemia, gout
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Contra-indication for allopurinol, benzbromaron or probenecid
2. Prior treatment with allopurinol, benzbromaron or probenecid
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Anticipated start date
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01/06/2005
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Anticipated end date
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31/05/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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96
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Interventions
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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)
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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1. Serum urate lowering effect (% decrease) of the antihyperuricemic agent
2. Tolerability of the antihyperuricemic agent (adverse drug reactions)
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Sources of funding
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Medical Centre Leeuwarden (The Netherlands)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18250112
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Contact name
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Dr
M K
Reinders
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Address
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Medical Centre Leeuwarden
Department of Clinical Pharmacy and Pharmacology
P.O. Box 888
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City/town
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Leeuwarden
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Zip/Postcode
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8901 BR
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Country
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Netherlands
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Tel
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+31 (0)58 286 6610
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Fax
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+31 (0)58 286 6606
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Email
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m.reinders@znb.nl
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Sponsor
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Medical Centre Leeuwarden (The Netherlands)
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Address
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Department of Clinical Pharmacy and Pharmacology
P.O. Box 888
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City/town
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Leeuwarden
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Zip/Postcode
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8901 BR
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Country
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Netherlands
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Date applied
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26/02/2007
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Last edited
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08/02/2008
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Date ISRCTN assigned
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26/02/2007
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