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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR903 |
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Date of registration:
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15/02/2007 |
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Primary sponsor: |
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Public title:
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Biochemical efficacy and tolerability of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in gout patients.
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Scientific title:
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Biochemical efficacy and tolerability of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in gout patients: a randomized controlled trial. - GOUT-2 |
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Date of first enrolment:
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1/9/2006 |
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Target sample size:
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60 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=903 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.K.
Reinders |
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Address:
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Medical Centre Leeuwarden
Department of Clinical Pharmacy and Pharmacology
Postbox 888
8901 BR
Leeuwarden
The Netherlands |
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Telephone:
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0031 58 2866610 |
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Email:
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m.reinders@znb.nl |
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Affiliation:
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Name:
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M.K.
Reinders |
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Address:
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Medical Centre Leeuwarden
Department of Clinical Pharmacy and Pharmacology
Postbox 888
8901 BR
Leeuwarden
The Netherlands |
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Telephone:
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0031 58 2866610 |
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Email:
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m.reinders@znb.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 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 criteria: 1. Contra-indication for study medication: allopurinol or benzbromarone;
2. Poor compliance on allopurinol defined as serum oxipurinol <5 mg/L.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Gout, Hyperuricemia
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Intervention(s)
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Arm 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.
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Primary Outcome(s)
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Success on study medication: tolerability and attainment of serum urate <0.30 mmol/L.
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Secondary Outcome(s)
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1. Relative decrease of serum urate;
2. Adverse drug reactions profile;
3. Pharmacokinetic analysis of serum oxipurinol levels.
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Secondary ID(s)
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ISRCTN49563848
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N/A
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Source(s) of Monetary Support
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Medical Centre Leeuwarden, Department of Clinical Pharmacy and Pharmacology
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