1. Allopurinol has a poor efficacy and tolerability profile to lower serum urate to target levels
ID
Bron
Verkorte titel
Aandoening
gout, hyperuricemia
Ondersteuning
Department of Clinical Pharmacy and Pharmacology,
Medical Centre Leeuwarden
Postbox 888
8901 BR Leeuwarden
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Success rate on study medication consisting of patient tolerability and attainment of target level serum urate <0.30 mmol/l after 8 weeks treatment.
Achtergrond van het onderzoek
1. 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).
Doel van het onderzoek
1. 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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
stage 1: allopurinol 1dd 300mg (8 weeks).
stage 2:
A. benzbromarone 1dd 200mg (8 weeks);
B. probenecide 2dd 1000mg (8 weeks).
Publiek
Department of Clinical Pharmacy and Pharmacology
Postbox 888
M.K. Reinders
Leeuwarden 8901 BR
The Netherlands
0031 58 2866610
m.reinders@znb.nl
Wetenschappelijk
Department of Clinical Pharmacy and Pharmacology
Postbox 888
M.K. Reinders
Leeuwarden 8901 BR
The Netherlands
0031 58 2866610
m.reinders@znb.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Contra-indication for allopurinol, benzbromaron or probenecid;
2. Prior treatment with allopurinol, benzbromaron or probenecid.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL886 |
| NTR-old | NTR901 |
| Ander register | : N/A |
| ISRCTN | ISRCTN21473387 |