No registrations found.
ID
Source
Brief title
Health condition
gout, hyperuricemia
Sponsors and support
Department of Clinical Pharmacy and Pharmacology,
Medical Centre Leeuwarden
Postbox 888
8901 BR Leeuwarden
The Netherlands
Intervention
Outcome measures
Primary outcome
Success rate on study medication consisting of patient tolerability and attainment of target level serum urate <0.30 mmol/l after 8 weeks treatment.
Secondary outcome
1. Serum urate lowering effect (% decrease) of the antihyperuricemic agent;
2. tolerability of the antihyperuricemic agent (adverse drug reactions).
Background summary
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).
Study objective
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.
Study design
N/A
Intervention
stage 1: allopurinol 1dd 300mg (8 weeks).
stage 2:
A. benzbromarone 1dd 200mg (8 weeks);
B. probenecide 2dd 1000mg (8 weeks).
Department of Clinical Pharmacy and Pharmacology
Postbox 888
M.K. Reinders
Leeuwarden 8901 BR
The Netherlands
0031 58 2866610
m.reinders@znb.nl
Department of Clinical Pharmacy and Pharmacology
Postbox 888
M.K. Reinders
Leeuwarden 8901 BR
The Netherlands
0031 58 2866610
m.reinders@znb.nl
Inclusion criteria
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.
Exclusion criteria
1. Contra-indication for allopurinol, benzbromaron or probenecid;
2. Prior treatment with allopurinol, benzbromaron or probenecid.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL886 |
| NTR-old | NTR901 |
| Other | : N/A |
| ISRCTN | ISRCTN21473387 |