Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
1 other identifier
interventional
395
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2002
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 16, 2002
CompletedFirst Posted
Study publicly available on registry
July 17, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedResults Posted
Study results publicly available
November 8, 2011
CompletedNovember 8, 2011
November 1, 2011
1.6 years
July 16, 2002
August 3, 2011
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment
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.
baseline and 12 months
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year
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)
baseline and 12 months
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo tablet
25 mg PG-530742
EXPERIMENTAL25 mg PG-530742
50 mg PG-530742
EXPERIMENTAL50 mg PG-530742
100 mg PG-530742
EXPERIMENTAL100 mg PG-530742
200 mg PG-530742
EXPERIMENTAL200 mg PG-530742
Interventions
Eligibility Criteria
You may qualify if:
- mild to moderate knee osteoarthritis confirmed by a radiographic technique.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Rehabilitation Hospital, Gizella telep
Visegrád, Gizella Telep, 2026, Hungary
Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
Győr, Hid Utica 2, 9025, Hungary
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40
Budapest, 1027, Hungary
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40
Budapest, 1027, Hungary
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40
Budapest, 1027, Hungary
Orthopedic Clinic, Karolina ut 17
Budapest, 1113, Hungary
Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.
Miskolc, 3529, Hungary
95 Stanwell Road
Ashford, Middlesex, TW15 3EA, United Kingdom
Royal National Orthapaedic Hsopital, Brackley Hill
Stanmore, Middlesex, HA 7 4LP, United Kingdom
St Thomas Hospital, Lambeth Place Road
London, Se17eh, United Kingdom
The Crouch Oak Practice, 45 Station Road, Addlestone
Addlestone, Surrey, KT15 2BH, United Kingdom
The Medical Centre, Kingston Avenue
East Horsley, Surrey, KT24 6QT, United Kingdom
Bridge House Medical Centre, Scholars Lane
Stratford-upon-Avon, Warwickshire, CV37 6HE, United Kingdom
Pound Hill Surgery, 1 Crawley Lane, Pound Hill
Crawley, West Sussex, RH10 7DX, United Kingdom
Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak
Birmingham, B29 6JD, United Kingdom
Synexus Birmingham Clinical Research Centre, Birmingham Research Park
Edgbaston, B15 2SQ, United Kingdom
Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells
Kent, TN 1 2DX, United Kingdom
Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road
London, E11 1NR, United Kingdom
Dept of Rheumatology Dulwich Hospital, East Dulwich
London, SE22 8PT, United Kingdom
Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
London Bridge, SE1 9RT, United Kingdom
Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens
Reading, RG2 7AG, United Kingdom
Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road
Tonbridge, TN10 3ET, United Kingdom
Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge
Wigan, WN6 9EW, United Kingdom
Related Publications (1)
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.
PMID: 17958901DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Thomas
- Organization
- Procter & Gamble
Study Officials
- STUDY DIRECTOR
John Beary, MD
Procter and Gamble
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2002
First Posted
July 17, 2002
Study Start
July 1, 2002
Primary Completion
February 1, 2004
Study Completion
February 1, 2004
Last Updated
November 8, 2011
Results First Posted
November 8, 2011
Record last verified: 2011-11