Randomised double blind trial of prednisone and naproxen in treatment of crystal proven acute gout

ISRCTN	ISRCTN14648181
DOI	https://doi.org/10.1186/ISRCTN14648181
Protocol serial number	N/A
Sponsor	University Medical Center St. Radboud (The Netherlands)
Funder	University Medical Center St. Radboud (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Eloy van de Lisdonk
Scientific

Department of General Practice and Family Medicine
Radboud University
P.O. Box 9191
Nijmegen
6500 HB
Netherlands

Phone	+31 (0)24 3615311
Email	e.vandelisdonk@hag.umcn.nl

Primary study design	Interventional
Study design	Randomised, double blind, active controlled, parallel group trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PREDJ-study (PREDnison Jicht = gout)
Study objectives	Active treatment of acute gouty arthritis by a short course of oral prednisone or naproxen are equal.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Acute gout
Intervention	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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Prednisone, naproxen
Primary outcome measure(s)	Patient assessment of pain in the study joint, indicated on visual analogical scales two times a day, during 4 days.
Key secondary outcome measure(s)	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
Completion date	01/06/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	120
Key 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.
Key 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
Date of first enrolment	01/04/2004
Date of final enrolment	01/06/2006

Department of General Practice and Family Medicine

Nijmegen
6500 HB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	31/05/2008		Yes	No