Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
03/06/2008
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 Eloy van de Lisdonk

ORCID ID

Contact details

Department of General Practice and Family Medicine
Radboud University
P.O. Box 9191
Nijmegen
6500 HB
Netherlands
+31 (0)24 3615311
e.vandelisdonk@hag.umcn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PREDJ-study (PREDnison Jicht = gout)

Study hypothesis

Active treatment of acute gouty arthritis by a short course of oral prednisone or naproxen are equal.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, double blind, active controlled, parallel group trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Prednisone, naproxen

Primary outcome measures

Patient assessment of pain in the study joint, indicated on visual analogical scales two times a day, during 4 days.

Secondary outcome measures

1. PatientsÂ’ global disability
2. The walking disability, if the study joint was in the leg or foot
3. Safety and tolerability of prednisone versus naproxen

Overall trial start date

01/04/2004

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120

Participant 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

Recruitment start date

01/04/2004

Recruitment end date

01/06/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of General Practice and Family Medicine
Nijmegen
6500 HB
Netherlands

Sponsor information

Organisation

University Medical Center St. Radboud (The Netherlands)

Sponsor details

Department of General Practice and Family Medicine
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcn.nl/homepage

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Center St. Radboud (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/18514729

Publication citations

  1. Results

    Janssens HJ, Janssen M, van de Lisdonk EH, van Riel PL, van Weel C, Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial., Lancet, 2008, 371, 9627, 1854-1860, doi: 10.1016/S0140-6736(08)60799-0.

Additional files

Editorial Notes