Condition category
Musculoskeletal Diseases
Date applied
23/11/2005
Date assigned
10/03/2006
Last edited
13/03/2006
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

Prof Josef Smolen

ORCID ID

Contact details

Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
Vienna
A-1090
Austria
+43 (0)140 400 4381
josef.smolen@wienkav.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IDS 04-05

Study information

Scientific title

Acronym

BELIOA2

Study hypothesis

The primary hypothesis is that patients with hand arthrosis treated with prednisolone for one week (3 days 50 mg, 4 days 25 mg) will improve significantly in different clinical parameters

Ethics approval

The study was approved by the Internal Review Board and Ethical Committee of the Vienna Medical University on 14/02/2006, reference number 481/2005

Study design

Single-centre, randomised, double-blind, placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hand arthrosis

Intervention

Patients are randomised to receive treatment with either prednisolone or naproxen or placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Prednisolone and naproxen

Primary outcome measures

Pain in the target hand measured on a 100 mm VAS

Secondary outcome measures

1. Morning stiffness
2. VAS for disease activity
3. Tender and swollen joint counts (inflammatory and bony swelling)
4. Functioning measured with:
a. Health Assessment Questionnaire (HAQ)
b. Score for Assessment and Quantification of Chronic Rheumatic Affections of the Hands (SACRAH)
c. Arthritis Impact Measurement Scales 2 - Short Form (AIMS2-SF)
d. Grip strength
e. Moberg picking-up test

Overall trial start date

01/12/2005

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Hand arthrosis
2. Age over 18 years
3. Pain on a 100 mm Visual Analogue Scale (VAS) in the target hand more than 40 mm
4. Willingness to comply with the protocol

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

246

Participant exclusion criteria

1. Current treatment with steroids
2. Cardiac insufficiency
3. Infection
4. Uncontrolled hypertension
5. History of gastrointestinal bleeding
6. Diabetes mellitus
7. Allergy against study medication
8. Pregnancy

Recruitment start date

01/12/2005

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Austria

Trial participating centre

Department of Internal Medicine III
Vienna
A-1090
Austria

Sponsor information

Organisation

Vienna Medical University (Austria)

Sponsor details

Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
Vienna
A-1090
Austria

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Vienna Medical University (Austria)

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

Publication citations

Additional files

Editorial Notes