| - candidate number | 2458 |
| - NTR Number | NTR901 |
| - ISRCTN | ISRCTN21473387 |
| - Date ISRCTN created | 26-feb-2007 |
| - date ISRCTN requested | 21-feb-2007 |
| - Date Registered NTR | 12-feb-2007 |
| - Secondary IDs | N/A |
| - Public Title | Biochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in gout. |
| - Scientific Title | Biochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in gout: a randomised controlled trial of benzbromarone versus probenecid after failure of allopurinol. |
| - ACRONYM | GOUT-1 |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Gout, Hyperuricemia |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-jun-2005 |
| - planned closingdate | 31-mei-2007 |
| - Target number of participants | 96 |
| - Interventions | stage 1: allopurinol 1dd 300mg (8 weeks). stage 2: A. benzbromarone 1dd 200mg (8 weeks); B. probenecide 2dd 1000mg (8 weeks). |
| - 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). |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | drs M.K. Reinders |
| - CONTACT for SCIENTIFIC QUERIES | drs 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 |
| - Publications | N/A |
| - Brief 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). |
| - Main changes (audit trail) | |
| - RECORD | 12-feb-2007 - 1-dec-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl