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Randomised double blind trial of prednisone and naproxen in treatment of crystal proven acute gout
ISRCTN ISRCTN14648181
DOI 10.1186/ISRCTN14648181
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised double blind trial of prednisone and naproxen in treatment of crystal proven acute gout
Scientific title
Acronym PREDJ-study (PREDnison Jicht = gout)
Serial number at source N/A
Study hypothesis Active treatment of acute gouty arthritis by a short course of oral prednisone or naproxen are equal.
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised, double blind, active controlled, parallel group trial.
Countries of recruitment Netherlands
Disease/condition/study domain Acute gout
Participants - inclusion criteria All patients referred to the rheumatology department of one hospital, by their general practitioner because of mono-arthritis, who proved to have urate crystals after diagnostic joint aspiration.
Participants - exclusion criteria 1. Use of anti-trombolytica
2. A history of peptic ulcer
3. A history of reduced renal function
4. A history of heart failure
5. A known hypersensitivity to naproxen and/or prednisone
6. Use of any Non-Steroidal Anti-Inflammatory Drug (NSAID) or prednisone within the past 12 hours
7. Unwillingness to participate
Anticipated start date 01/04/2004
Anticipated end date 01/06/2006
Status of trial Completed
Patient information material
Target number of participants 120
Interventions Five days, by oral administration, either prednisolone 35 mg (= 30 mg prednisone) once a day or naproxen at a dose of 500 mg twice a day. Patients received blind capsules containing active prednisolone and placebo naproxen, or active naproxen and placebo prednisolone.
Primary outcome measure(s) Patient assessment of pain in the study joint, indicated on visual analogical scales two times a day, during 4 days.
Secondary outcome measure(s) 1. Patientsí global disability
2. The walking disability, if the study joint was in the leg or foot
3. Safety and tolerability of prednisone versus naproxen
Sources of funding University Medical Center St. Radboud (The Netherlands)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18514729
Contact name Dr  Eloy  van de Lisdonk
  Address Department of General Practice and Family Medicine
Radboud University
P.O. Box 9191
  City/town Nijmegen
  Zip/Postcode 6500 HB
  Country Netherlands
  Tel +31 (0)24 3615311
  Email e.vandelisdonk@hag.umcn.nl
Sponsor University Medical Center St. Radboud (The Netherlands)
  Address Department of General Practice and Family Medicine
P.O. Box 9101
  City/town Nijmegen
  Zip/Postcode 6500 HB
  Country Netherlands
  Sponsor website: http://www.umcn.nl/homepage
Date applied 20/12/2005
Last edited 03/06/2008
Date ISRCTN assigned 20/12/2005
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