Randomised controlled trial for the treatment of hand arthrosis with prednisolone and naproxen
| ISRCTN | ISRCTN68990076 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68990076 |
| Secondary identifying numbers | IDS 04-05 |
- Submission date
- 23/11/2005
- Registration date
- 10/03/2006
- Last edited
- 13/03/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Josef Smolen
Scientific
Scientific
Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
Vienna
A-1090
Austria
| Phone | +43 (0)140 400 4381 |
|---|---|
| josef.smolen@wienkav.at |
Study information
| Study design | Single-centre, randomised, double-blind, placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | BELIOA2 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | Hand arthrosis |
| Intervention | Patients are randomised to receive treatment with either prednisolone or naproxen or placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prednisolone and naproxen |
| Primary outcome measure | 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 study start date | 01/12/2005 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 246 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Austria
Study participating centre
Department of Internal Medicine III
Vienna
A-1090
Austria
A-1090
Austria
Sponsor information
Vienna Medical University (Austria)
University/education
University/education
Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
Vienna
A-1090
Austria
"ROR" |
https://ror.org/05n3x4p02 |
|---|
Funders
Funder type
University/education
Vienna Medical University (Austria)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
