Condition category
Musculoskeletal Diseases
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
18/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M K Reinders

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR903

Study information

Scientific title

Acronym

GOUT-2

Study hypothesis

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

Ethics approval received from the Medical Centre Leeuwarden on the 13th March 2006 (ref: TPO-412).

Study design

Randomised, active controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Allopurinol, benzbroamrone

Primary outcome measures

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 trial start date

01/09/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/09/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Medical Centre Leeuwarden
Leeuwarden
8901 BR
Netherlands

Sponsor information

Organisation

Medical Centre Leeuwarden (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Medical Centre Leeuwarden (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results inhttp://www.ncbi.nlm.nih.gov/pubmed/18633127

Publication citations

  1. Reinders MK, Haagsma C, Jansen TL, van Roon EN, Delsing J, van de Laar MA, Brouwers JR, A randomised controlled trial on the efficacy and tolerability with dose escalation of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in patients with gout., Ann. Rheum. Dis., 2009, 68, 6, 892-897, doi: 10.1136/ard.2008.091462.

Additional files

Editorial Notes