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

• Conditions: Osteoarthritis of the hands

• Registration Number: EUCTR2005-005442-39-AT
• Lead Sponsor: Division of Rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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