|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR901 |
|
Date of registration:
|
12/02/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Biochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in gout.
|
|
Scientific title:
|
Biochemical efficacy and tolerability of allopurinol, benzbromarone and probenecid in gout: a randomised controlled trial of benzbromarone versus probenecid after failure of allopurinol. - GOUT-1 |
|
Date of first enrolment:
|
1/6/2005 |
|
Target sample size:
|
96 |
|
Recruitment status: |
complete |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=901 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
M.K.
Reinders |
|
Address:
|
Medical Centre Leeuwarden
Department of Clinical Pharmacy and Pharmacology
Postbox 888
8901 BR
Leeuwarden
The Netherlands |
|
Telephone:
|
0031 58 2866610 |
|
Email:
|
m.reinders@znb.nl |
|
Affiliation:
|
|
|
|
Name:
|
M.K.
Reinders |
|
Address:
|
Medical Centre Leeuwarden
Department of Clinical Pharmacy and Pharmacology
Postbox 888
8901 BR
Leeuwarden
The Netherlands |
|
Telephone:
|
0031 58 2866610 |
|
Email:
|
m.reinders@znb.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Age >18 year;
2. Diagnosis gout based on crystal evidence or ARA criteria;
3. Eestimated creatinine clearance >50 ml/min;
4. Baseline values measured: serum urate, urinary urate excretion, serum creatinine.
Exclusion criteria: 1. Contra-indication for allopurinol, benzbromaron or probenecid;
2. Prior treatment with allopurinol, benzbromaron or probenecid.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Gout, Hyperuricemia
|
|
Intervention(s)
|
stage 1: allopurinol 1dd 300mg (8 weeks).
stage 2:
A. benzbromarone 1dd 200mg (8 weeks);
B. probenecide 2dd 1000mg (8 weeks).
|
|
Primary Outcome(s)
|
|
Success rate on study medication consisting of patient tolerability and attainment of target level serum urate <0.30 mmol/l after 8 weeks treatment.
|
|
Secondary Outcome(s)
|
1. Serum urate lowering effect (% decrease) of the antihyperuricemic agent;
2. tolerability of the antihyperuricemic agent (adverse drug reactions).
|
|
Secondary ID(s)
|
|
ISRCTN21473387
|
|
N/A
|
|
Source(s) of Monetary Support
|
|
Medical Centre Leeuwarden, Department of Clinical Pharmacy and Pharmacology
|
|