Biochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in GOUT

ISRCTN ISRCTN21473387
DOI https://doi.org/10.1186/ISRCTN21473387
Secondary identifying numbers N/A
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

Medical Centre Leeuwarden
Department of Clinical Pharmacy and Pharmacology
P.O. Box 888
Leeuwarden
8901 BR
Netherlands

+31 (0)58 286 6610
m.reinders@znb.nl

Study information

Study designRandomised, active controlled, parallel group, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymGOUT-1
Study objectives1. 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) studiedHyperuricemia, gout
InterventionStage 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Allopurinol, benzbromarone, probenecide
Primary outcome measureSuccess 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.
Secondary outcome measures1. Serum urate lowering effect (% decrease) of the antihyperuricemic agent
2. Tolerability of the antihyperuricemic agent (adverse drug reactions)
Overall study start date01/06/2005
Completion date31/05/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants96
Key inclusion criteria1. 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 criteria1. Contra-indication for allopurinol, benzbromaron or probenecid
2. Prior treatment with allopurinol, benzbromaron or probenecid
Date of first enrolment01/06/2005
Date of final enrolment31/05/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Medical Centre Leeuwarden
Leeuwarden
8901 BR
Netherlands

Sponsor information

Funders

Funder type

Hospital/treatment centre

Medical Centre Leeuwarden (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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