Randomized controlled trial of prednisolone in the treatment of osteaoarthritis of the hand - BELIOA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005442-39-AT

Enrollment

250

Registered

2006-10-19

Start date

2006-10-24

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the hands

Interventions

Trade Name: Aprednislon Product Name: Aprednislon Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Naproxen P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >18 Jahre Obtained written informed consent Osteoarthritis of the hands according to the criteria of the AMerican College of Rheumatology, including patients with bony swelling/overgrowth in at least one proximal or distal interphalangeal joint or one carpo-metacarpal joint. Active disease, defined as pain in the hands =40mm (on a 100mm visual analogue scale). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Current therapy with oral steroids: Prednisolon >10mg/Tag Infections : defined by (a) respective clinical signs and symptoms, or (b) fever >37°C during the past 48h, or (c) leukocytosis >12 G/L. Uncontrolled congestive heart failure: defined as (a) right cardiac failure with peripheral edema, or (b) left cardiac failure with dyspnoe (NYHA II-IV) Diabetes Mellitus: defined by (a) therapy with oral antidiabetics, or (b) therapy with insulin, or (c) abnormal fasting blood glucose levels Insufficianetly controlled hypertension: defined as (a) systolischer blood pressure >160 mmHg, or (b) diastolic blood pressure >90 mmHg GI bleeding or history of GI bleeding Known allergic reactions to non-steroidal anti-rheumatic drugs including naproxen Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the clinical efficacy of prednisolone in the treatment of osteoarthritis of the hands;Secondary Objective: assess the clinical efficacy of naproxen and the comnparative efficacy of prednisolone and naproxen in the treatment of osteoarthritis of the hands;Primary end point(s): Improvement of hand pain	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026