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
Secondary identifying numbers	NTR903

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

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 information

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	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Allopurinol, benzbroamrone
Primary outcome measure	Success on study medication: tolerability and attainment of serum urate less than 0.30 mmol/L
Secondary outcome measures	1. Relative decrease of serum urate 2. Adverse drug reactions profile 3. Pharmacokinetic analysis of serum oxipurinol levels
Overall study start date	01/09/2006
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Sponsor information

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

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 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	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