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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M K Reinders
Scientific

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

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

Study design	Randomised, active controlled, parallel group, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Allopurinol, benzbromarone, probenecide
Primary outcome measure	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.
Secondary outcome measures	1. Serum urate lowering effect (% decrease) of the antihyperuricemic agent 2. Tolerability of the antihyperuricemic agent (adverse drug reactions)
Overall study start date	01/06/2005
Completion date	31/05/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	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

Medical Centre Leeuwarden

Leeuwarden
8901 BR
Netherlands

Medical Centre Leeuwarden (The Netherlands)
Hospital/treatment centre

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

"ROR"	https://ror.org/0283nw634

Hospital/treatment centre

Medical Centre Leeuwarden (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/01/2009		Yes	No