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Biochemical efficacy and tolerability of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in gout patients.


- candidate number2460
- NTR NumberNTR903
- ISRCTNISRCTN49563848
- Date ISRCTN created26-feb-2007
- date ISRCTN requested21-feb-2007
- Date Registered NTR15-feb-2007
- Secondary IDsN/A 
- Public TitleBiochemical efficacy and tolerability of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in gout patients.
- Scientific TitleBiochemical efficacy and tolerability of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in gout patients: a randomized controlled trial.
- ACRONYMGOUT-2
- hypothesisAttainment of target serum urate levels seems more succesfull with benzbromarone 100 mg/day than with allopurinol 300 mg/day [Perez-Ruiz, 1998]. We study whether allopurinol 600 mg/day provides a better success rate in attaining target serum urate levels.
- Healt Condition(s) or Problem(s) studiedGout, Hyperuricemia
- Inclusion criteria1. Diagnosis based on crystal evidence or otherwise meeting the ARA criteria;
2. Baseline serum urate measured;
3. Baseline urinary urate excretion measured;
4. Estimated creatinine clearance >50 mL/min.
- Exclusion criteria1. Contra-indication for study medication: allopurinol or benzbromarone;
2. Poor compliance on allopurinol defined as serum oxipurinol <5 mg/L.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2006
- planned closingdate31-dec-2007
- Target number of participants60
- InterventionsArm A: 1dd 300mg allopurinol, when serum urate exceeds 0.30 mmol/L after 8 weeks, dosage is increased to 2dd 300mg;
Arm B: 1dd 100mg benzbroamrone, when serum urate exceeds 0.30 mmol/L after 8 weeks, dosage is increased to 1dd 200mg.
- Primary outcomeSuccess on study medication: tolerability and attainment of serum urate <0.30 mmol/L.
- Secondary outcome1. Relative decrease of serum urate;
2. Adverse drug reactions profile;
3. Pharmacokinetic analysis of serum oxipurinol levels.
- 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 Centre Leeuwarden, Department of Clinical Pharmacy and Pharmacology
- PublicationsN/A
- Brief summaryBiochemical efficacy and tolerability of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day is studied in gout patients in a randomized controlled trial. Success rate in tolerability plus attaining serum urate <0.30 mmol/L is analyzed.
- Main changes (audit trail)
- RECORD15-feb-2007 - 18-jan-2010


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