Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Interventions
- Registration Number
- NCT00041756
- Lead Sponsor
- Procter and Gamble
- Brief Summary
Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742 inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.
- Detailed Description
Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 395
- mild to moderate knee osteoarthritis confirmed by a radiographic technique.
- secondary knee osteoarthritis;
- diseases other than osteoarthritis that could cause knee pain;
- any disease or intervention (surgery, intra-articular injection) that would have an impact on knee pain or mobility;
- drugs that act potentially on the bone or cartilage component of the knee joint.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo tablet 25 mg PG-530742 PG-530742 25 mg PG-530742 100 mg PG-530742 100 mg PG-530742 100 mg PG-530742 50 mg PG-530742 50 mg PG-530742 50 mg PG-530742 200 mg PG-530742 200 mg PG-530742 200 mg PG-530742
- Primary Outcome Measures
Name Time Method Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment baseline and 12 months The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year baseline and 12 months The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Rehabilitation Hospital, Gizella telep
🇭🇺Visegrad, Gizella telep, Hungary
Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
🇭🇺Gyor, Hid Utica 2, Hungary
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40
🇭🇺Budapest, Hungary
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40
🇭🇺Budapest, Hungary
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40
🇭🇺Budapest, Hungary
Orthopedic Clinic, Karolina ut 17
🇭🇺Budapest, Hungary
Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.
🇭🇺Miskolc, Hungary
95 Stanwell Road
🇬🇧Ashford, Middlesex, United Kingdom
Royal National Orthapaedic Hsopital, Brackley Hill
🇬🇧Stanmore, Middlesex, United Kingdom
St Thomas Hospital, Lambeth Place Road
🇬🇧London, Se17eh, United Kingdom
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