Investigaton of Safety, Tolerability of two preparations in patients suffering from osteoarthritis of the hip or knee

• Conditions: Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Osteoarthritis of the hip or knee

• Registration Number: EUCTR2009-010719-33-AT
• Lead Sponsor: Gebro Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-30
• Last Update Posted: 21 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

male or female patients; age between 18 and 85 years; informed consent of the patient; everyday joint pain for the past three months; global pain intensity in the involved joint (hip or knee) of moderate” to severe” within the last 48 h [on the Likertscale: mild, moderate, severe, extreme]: mild: no impairment of the quality of life, no disorder of night pain, pain at different functions less than 1 hourmoderate: recognizable impairment of the quality of life, pain at single functional sequences, pain dimension is limited to any time of the daysevere: pain impairment of the quality of life at numerous activities of daily lifeextreme: marked impairment of the quality of life over 24h attached with clear pain description; previous treatment with NSAIDs with half-life of > 12 hours after a wash-out period of 5 times of half-life
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

Acute inflammation; ischaemic necrosis; paget’s disease of the hip/knee joint; chondrocalcinosis of the hip/knee joint; ochronosis of the hip/knee joint; haematochromatosis of the hip/knee joint; hip/knee arthropathy in haemophiliacs; unilateral or bilateral inflammatory hip/knee arhtropathy as single manifestation (CP, Bechterew’s disease, psoriasis etc.) with and without involvement of other joints; infectious; slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology; hip/knee arthropathy due to diabetes mellitus; Charcot’s joint; villous sinovitis; chondromatosis of the synovium; contraindication of the trial substance (see SmPC); patients tending to allergies or hypersensitivity to non-steroidal anti-inflammatory agents (triggering asthma attacks or history of urticaria or acute rhinitis); patients with existing gastritis or existing ulcers or bleedings in the gastrointestinal tract or patients with history of gastrointestinal ulcers or gastrointestinal haemorrhage in the past 6 months; patients with chronic respiratory tract infections, asthma; patients with impaired haematopoesis, porphyria, haemorrhagic diathesis; several renal or hepatic disease; uncontrolled hypertension (constant random diastolic blood pressure in spite of regular medication of at least two measurements > 180 and/or 110); severe heart failure (NYHA III-IV); decompensated diabetes mellitus (at requirement: bland-blood sugar over 400 mg/dl); patients with autoimmune disease (e.g. lupus erythematodes); positive urine pregnancy test at the onset of trial (if required); pregnant woman; breast-feeding woman; adolescents and children; participation in another clinical trial less than 30 days ago; simultaneous participation in another clinical trial

Study & Design

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