Condition category
Musculoskeletal Diseases
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
08/02/2008
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

N/A

Study information

Scientific title

Acronym

GOUT-1

Study hypothesis

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

Ethics approval received by the Medical Centre Leeuwarden on the 7th February 2005 (ref: TPO-357).

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

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

Phase

Not Specified

Drug names

Allopurinol, benzbromarone, probenecide

Primary outcome measures

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 trial start date

01/06/2005

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

96

Participant exclusion criteria

1. Contra-indication for allopurinol, benzbromaron or probenecid
2. Prior treatment with allopurinol, benzbromaron or probenecid

Recruitment start date

01/06/2005

Recruitment end date

31/05/2007

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 in http://www.ncbi.nlm.nih.gov/pubmed/18250112

Publication citations

  1. Results

    Reinders MK, van Roon EN, Jansen TL, Delsing J, Griep EN, Hoekstra M, van de Laar MA, Brouwers JR, Efficacy and tolerability of urate-lowering drugs in gout: a randomised controlled trial of benzbromarone versus probenecid after failure of allopurinol., Ann. Rheum. Dis., 2009, 68, 1, 51-56, doi: 10.1136/ard.2007.083071.

Additional files

Editorial Notes