Biochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in GOUT
| ISRCTN | ISRCTN21473387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21473387 |
| Protocol serial number | N/A |
| Sponsor | Medical Centre Leeuwarden (The Netherlands) |
| Funder | Medical Centre Leeuwarden (The Netherlands) |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 08/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M K Reinders
Scientific
Scientific
Medical Centre Leeuwarden
Department of Clinical Pharmacy and Pharmacology
P.O. Box 888
Leeuwarden
8901 BR
Netherlands
| Phone | +31 (0)58 286 6610 |
|---|---|
| m.reinders@znb.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | GOUT-1 |
| Study objectives | 1. Allopurinol has a poor efficacy and tolerability profile to lower serum urate to target levels less than 0.30 mmol/l 2. Benzbromarone is more potent and is better tolerated than probenecid to lower serum urate to target levels less than 0.30 mmol/l |
| Ethics approval(s) | Ethics approval received by the Medical Centre Leeuwarden on the 7th February 2005 (ref: TPO-357). |
| Health condition(s) or problem(s) studied | Hyperuricemia, gout |
| Intervention | Stage 1: allopurinol 1dd 300 mg (eight weeks) Stage 2: 1. Benzbromarone 1dd 200 mg (eight weeks), or 2. Probenecide 2dd 1000 mg (eight weeks) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Allopurinol, benzbromarone, probenecide |
| Primary outcome measure(s) |
Success rate on study medication consisting of patient tolerability and attainment of target level serum urate less than 0.30 mmol/l after eight weeks treatment. |
| Key secondary outcome measure(s) |
1. Serum urate lowering effect (% decrease) of the antihyperuricemic agent |
| Completion date | 31/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 96 |
| Key inclusion criteria | 1. Aged greater than 18 years 2. Diagnosis gout based on crystal evidence or American Rheumatism Association (ARA) criteria 3. Eestimated creatinine clearance more than 50 ml/min 4. Baseline values measured: serum urate, urinary urate excretion, serum creatinine |
| Key exclusion criteria | 1. Contra-indication for allopurinol, benzbromaron or probenecid 2. Prior treatment with allopurinol, benzbromaron or probenecid |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 31/05/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Medical Centre Leeuwarden
Leeuwarden
8901 BR
Netherlands
8901 BR
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/01/2009 | Yes | No |
