A phase II, 12-month, double-blind, placebo-controlled, dose-finding, multicenter study to evaluate the safety, tolerability, and disease modifying efficacy of daily oral AAE581 (10, 25 and 50 mg tablets) in patients with painful knee osteoarthritis, Kellgren-Lawrence grade 3 by X-ray - 2201
- Conditions
- Osteoarthritis (OA) is a disease with a complex pathophysiology leading to the degeneration of articular cartilage and bone. It is characterized by pain, biochemical and enzymatic changes, cartilage loss, osteophyte formation and bone sclerosis. The pathological changes can be focal or more generalized and often correlate poorly with clinical symptoms and signs. Most available treatments act on symptoms (e.g. pain) without any benefits on the structural changes caused by OA.
- Registration Number
- EUCTR2004-001754-92-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 208
1. Male and female patients with knee osteoarthritis aged from 40 to 80 years old.
2. Patients having at least one knee with OA with Kellgren and Lawrence grade 3. The other knee can be Kellgren and Lawrence grade 0 to 4. Patients should have significant OA pain in the knee (VAS > 40/100 mm) for most of the days in the past month. Patients who are controlled with analgesic medication are also allowed in the study provided their OA pain would be significant without this treatment.
3. Patients with elevated levels of CTX-II (value > 300 ng/mmol creatinine)
4. Patients suffering from osteoarthritis with at least one of the following risk facotrs:
Obesity (BMI > 28)
OA present at other sites, e.g. the hand, hip or spine
Effusion in the target knee by clinical exam
Family history of Total Joint Replacement
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
1. Women with childbearing potential, e.g. post-menopausal for less than two years or with serum follicle stimulating hormone (FSH) level = 40 IU/ml, estradiol > 20 pg/mL or not surgically sterilized
2. Conditions causing secondary OA, primary fibromyalgia
3. Patients with current history or present signs of severe or uncontrolled renal insufficiency (serum creatinine >=125% ULN or presence of proteinuria (dipstick + or greater) not assosiated with urinary tract infection or evidence of sample contamination), hepatic (AST, ALT>= 150% ULN), hematological, cardiac, pulmonary, neurological, or cerebral disease.
4. Treatment with Intraarticular corticosteroids in the target knee within the past 3 months, Intraarticular hyaluronic acid injections in the target knee within the past 6 months
5. Knee surgery within the past 12 months and any planned knee surgery during the course of the study (including artheroscopy)
6. Patients with a BMI = 34
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method