Clinical trial NCT00041756: Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
Official title: Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Primary Disease: Knee Primary Osteoarthritis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2002-07-17
Enrollment: 395
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* mild to moderate knee osteoarthritis confirmed by a radiographic technique.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment
timeFrame: baseline and 12 months
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year
timeFrame: baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Visegrad
country: Hungary
facility: Rehabilitation Hospital, Gizella telep
state: Gizella telep
city: Gyor
country: Hungary
facility: Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
state: Hid Utica 2
city: Budapest
country: Hungary
facility: National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40
city: Budapest
country: Hungary
facility: National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40
city: Budapest
country: Hungary
facility: National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40
city: Budapest
country: Hungary
facility: Orthopedic Clinic, Karolina ut 17
city: Miskolc
country: Hungary
facility: Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.
city: Ashford
country: United Kingdom
facility: 95 Stanwell Road
state: Middlesex
city: Stanmore
country: United Kingdom
facility: Royal National Orthapaedic Hsopital, Brackley Hill
state: Middlesex
city: London
country: United Kingdom
facility: St Thomas Hospital, Lambeth Place Road
state: Se17eh
city: Addlestone
country: United Kingdom
facility: The Crouch Oak Practice, 45 Station Road, Addlestone
state: Surrey
city: East Horsley
country: United Kingdom
facility: The Medical Centre, Kingston Avenue
state: Surrey
city: Stratford-upon-avon
country: United Kingdom
facility: Bridge House Medical Centre, Scholars Lane
state: Warwickshire
city: Crawley
country: United Kingdom
facility: Pound Hill Surgery, 1 Crawley Lane, Pound Hill
state: West Sussex
city: Birmingham
country: United Kingdom
facility: Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak
city: Edgbaston
country: United Kingdom
facility: Synexus Birmingham Clinical Research Centre, Birmingham Research Park
city: Kent
country: United Kingdom
facility: Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells
city: London Bridge
country: United Kingdom
facility: Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
city: London
country: United Kingdom
facility: Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road
city: London
country: United Kingdom
facility: Dept of Rheumatology Dulwich Hospital, East Dulwich
city: Reading
country: United Kingdom
facility: Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens
city: Tonbridge
country: United Kingdom
facility: Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road
city: Wigan
country: United Kingdom
facility: Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge
Study officials:
affiliation: Procter and Gamble
name: John Beary, MD
role: STUDY_DIRECTOR
References:
citation: Krzeski P, Buckland-Wright C, Balint G, Cline GA, Stoner K, Lyon R, Beary J, Aronstein WS, Spector TD. Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study. Arthritis Res Ther. 2007;9(5):R109. doi: 10.1186/ar2315.