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van CCT (UK)


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van CCT (UK)


Biochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in gout.


- candidate number2458
- NTR NumberNTR901
- ISRCTNISRCTN21473387
- Date ISRCTN created26-feb-2007
- date ISRCTN requested21-feb-2007
- Date Registered NTR12-feb-2007
- Secondary IDsN/A 
- Public TitleBiochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in gout.
- Scientific TitleBiochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in gout: a randomised controlled trial of benzbromarone versus probenecid after failure of allopurinol.
- ACRONYMGOUT-1
- hypothesis1. Allopurinol has a poor efficacy and tolerability profile to lower serum urate to target levels <0.30 mmol/l.
2. Benzbromarone is more potent and is better tolerated than probenecid to lower serum urate to target levels <0.30 mmol/l.
- Healt Condition(s) or Problem(s) studiedGout, Hyperuricemia
- Inclusion criteria1. Age >18 year;
2. Diagnosis gout based on crystal evidence or ARA criteria;
3. Eestimated creatinine clearance >50 ml/min;
4. Baseline values measured: serum urate, urinary urate excretion, serum creatinine.
- Exclusion criteria1. Contra-indication for allopurinol, benzbromaron or probenecid;
2. Prior treatment with allopurinol, benzbromaron or probenecid.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2005
- planned closingdate31-mei-2007
- Target number of participants96
- Interventionsstage 1: allopurinol 1dd 300mg (8 weeks).
stage 2:
A. benzbromarone 1dd 200mg (8 weeks);
B. probenecide 2dd 1000mg (8 weeks).
- Primary outcomeSuccess rate on study medication consisting of patient tolerability and attainment of target level serum urate <0.30 mmol/l after 8 weeks treatment.
- Secondary outcome1. Serum urate lowering effect (% decrease) of the antihyperuricemic agent;
2. tolerability of the antihyperuricemic agent (adverse drug reactions).
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESdrs M.K. Reinders
- CONTACT for SCIENTIFIC QUERIESdrs M.K. Reinders
- Sponsor/Initiator Medical Centre Leeuwarden, Department of Clinical Pharmacy and Pharmacology
- Funding
(Source(s) of Monetary or Material Support)
Medical Centrer Leeuwarden
- PublicationsN/A
- Brief summary1. To study the efficacy and tolerability of the uricostatic agent allopurinol 300 mg/day to decrease serum-urate to target values of <0.30 mmol/l in gout patients (stage 1).
2. To compare the efficacy and tolerability of the uricosuric agents benzbromarone 200 mg/day and probenecid 2000 mg/day to decrease serum urate to target values <0.30 mmol/l in gout patients inadequately treated with allopurinol (stage 2).
- Main changes (audit trail)
- RECORD12-feb-2007 - 1-dec-2009


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