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ISRCTN
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ISRCTN14648181
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DOI
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10.1186/ISRCTN14648181
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Randomised double blind trial of prednisone and naproxen in treatment of crystal proven acute gout
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Scientific title
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Acronym
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PREDJ-study (PREDnison Jicht = gout)
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Serial number at source
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N/A
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Study hypothesis
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Active treatment of acute gouty arthritis by a short course of oral prednisone or naproxen are equal.
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised, double blind, active controlled, parallel group trial.
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Acute gout
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2004
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Anticipated end date
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01/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120
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Interventions
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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.
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Primary outcome measure(s)
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Patient assessment of pain in the study joint, indicated on visual analogical scales two times a day, during 4 days.
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Secondary outcome measure(s)
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1. Patients’ global disability
2. The walking disability, if the study joint was in the leg or foot
3. Safety and tolerability of prednisone versus naproxen
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Sources of funding
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University Medical Center St. Radboud (The Netherlands)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18514729
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Contact name
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Dr
Eloy
van de Lisdonk
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Address
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Department of General Practice and Family Medicine
Radboud University
P.O. Box 9191
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City/town
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Nijmegen
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Zip/Postcode
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6500 HB
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Country
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Netherlands
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Tel
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+31 (0)24 3615311
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Email
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e.vandelisdonk@hag.umcn.nl
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Sponsor
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University Medical Center St. Radboud (The Netherlands)
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Address
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Department of General Practice and Family Medicine
P.O. Box 9101
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City/town
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Nijmegen
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Zip/Postcode
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6500 HB
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Country
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Netherlands
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Sponsor website:
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http://www.umcn.nl/homepage
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Date applied
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20/12/2005
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Last edited
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03/06/2008
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Date ISRCTN assigned
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20/12/2005
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