Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
NCT ID: NCT00041756
Last Updated: 2011-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
395 participants
INTERVENTIONAL
2002-07-31
2004-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo tablet
Placebo
One placebo tablet, twice daily for for one year
25 mg PG-530742
25 mg PG-530742
PG-530742
One 25 mg PG-530742 tablet, twice daily for for one year
50 mg PG-530742
50 mg PG-530742
50 mg PG-530742
One 50 mg PG-530742 tablet, twice daily for for one year
100 mg PG-530742
100 mg PG-530742
100 mg PG-530742
100 mg PG-530742 tablet, twice a day for one year
200 mg PG-530742
200 mg PG-530742
200 mg PG-530742
200 mg PG-530742 tablet, twice a day for one year
Interventions
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PG-530742
One 25 mg PG-530742 tablet, twice daily for for one year
Placebo
One placebo tablet, twice daily for for one year
50 mg PG-530742
One 50 mg PG-530742 tablet, twice daily for for one year
100 mg PG-530742
100 mg PG-530742 tablet, twice a day for one year
200 mg PG-530742
200 mg PG-530742 tablet, twice a day for one year
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
No
Sponsors
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Procter and Gamble
INDUSTRY
Responsible Party
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Principal Investigators
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John Beary, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Rehabilitation Hospital, Gizella telep
Visegrád, Gizella Telep, Hungary
Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
Győr, 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
The Crouch Oak Practice, 45 Station Road, Addlestone
Addlestone, Surrey, United Kingdom
The Medical Centre, Kingston Avenue
East Horsley, Surrey, United Kingdom
Bridge House Medical Centre, Scholars Lane
Stratford-upon-Avon, Warwickshire, United Kingdom
Pound Hill Surgery, 1 Crawley Lane, Pound Hill
Crawley, West Sussex, United Kingdom
Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak
Birmingham, , United Kingdom
Synexus Birmingham Clinical Research Centre, Birmingham Research Park
Edgbaston, , United Kingdom
Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells
Kent, , United Kingdom
Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road
London, , United Kingdom
Dept of Rheumatology Dulwich Hospital, East Dulwich
London, , United Kingdom
Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
London Bridge, , United Kingdom
Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens
Reading, , United Kingdom
Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road
Tonbridge, , United Kingdom
Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge
Wigan, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2001065
Identifier Type: -
Identifier Source: org_study_id