Biochemical efficacy and tolerability of allopurinol 300 - 600 mg/day versus benzbromarone 100 - 200 mg/day in GOUT patients
| ISRCTN | ISRCTN49563848 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49563848 |
| Protocol serial number | NTR903 |
| Sponsor | Medical Centre Leeuwarden (The Netherlands) |
| Funder | Medical Centre Leeuwarden (The Netherlands) |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 27/10/2022
- 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 | Biochemical efficacy and tolerability of allopurinol 300 - 600 mg/day versus benzbromarone 100 - 200 mg/day in GOUT patients |
| Study acronym | GOUT-2 |
| Study objectives | Attainment of target serum urate levels seems more succesful with benzbromarone 100 mg/day than with allopurinol 300 mg/day. We study whether allopurinol 600 mg/day provides a better success rate in attaining target serum urate levels. |
| Ethics approval(s) | Ethics approval received from the Medical Centre Leeuwarden on the 13th March 2006 (ref: TPO-412). |
| Health condition(s) or problem(s) studied | Hyperuricemia, gout |
| Intervention | Arm A: 1dd 300 mg allopurinol, when serum urate exceeds 0.30 mmol/L after eight weeks, dosage is increased to 2dd 300 mg Arm B: 1dd 100 mg benzbroamrone, when serum urate exceeds 0.30 mmol/L after eight weeks, dosage is increased to 1dd 200 mg |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Allopurinol, benzbroamrone |
| Primary outcome measure(s) |
Success on study medication: tolerability and attainment of serum urate less than 0.30 mmol/L |
| Key secondary outcome measure(s) |
1. Relative decrease of serum urate |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 65 |
| Key inclusion criteria | 1. Diagnosis based on crystal evidence or otherwise meeting the American Rheumatology Association (ARA) criteria 2. Baseline serum urate measured 3. Baseline urinary urate excretion measured 4. Estimated creatinine clearance more than 50 mL/min |
| Key exclusion criteria | 1. Contra-indication for study medication: allopurinol or benzbromarone 2. Poor compliance on allopurinol defined as serum oxipurinol less than 5 mg/L |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 31/12/2007 |
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2009 | Yes | No |
Editorial Notes
27/10/2022: The final enrolment number has been added from the results reference
