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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00041756 |
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.
Condition | Intervention | Phase |
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Osteoarthritis, Knee |
Drug: PG-530742 Drug: Placebo tablet, Drug: 50 mg PG-530742 Drug: 100 mg PG-530742 Drug: 200 mg PG-530742 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis |
Enrollment: | 401 |
Study Start Date: | January 2002 |
Study Completion Date: | February 2004 |
Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo tablet
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Drug: Placebo tablet,
One placebo tablet, twice daily for for one year
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2: Experimental
25 mg PG-530742
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Drug: PG-530742
One 25 mg PG-530742, twice daily for for one year
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3: Experimental
50 mg PG-530742
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Drug: 50 mg PG-530742
One 50 mg PG-530742, twice daily for for one year
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4: Experimental
100 mg PG-530742
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Drug: 100 mg PG-530742
100 mg PG-530742 tablet, twice a day for one year
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5: Experimental
200 mg PG-530742
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Drug: 200 mg PG-530742
200 mg PG-530742 tablet, twice a day for one year
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Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Hungary | |
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40 | |
Budapest, Hungary, 1027 | |
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40 | |
Budapest, Hungary, 1027 | |
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40 | |
Budapest, Hungary, 1027 | |
Orthopedic Clinic, Karolina ut 17 | |
Budapest, Hungary, 1113 | |
Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42. | |
Miskolc, Hungary, 3529 | |
Hungary, Gizella telep | |
Rehabilitation Hospital, Gizella telep | |
Visegrad, Gizella telep, Hungary, 2026 | |
Hungary, Hid Utica 2 | |
Petz A. Country Hospital, Department of Rheumatology, Hid utca 2. | |
Gyor, Hid Utica 2, Hungary, 9025 | |
United Kingdom | |
Dept of Rheumatology Dulwich Hospital, East Dulwich | |
London, United Kingdom, SE22 8PT | |
Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road | |
London, United Kingdom, E11 1NR | |
Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak | |
Birmingham, United Kingdom, B29 6JD | |
Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House | |
London Bridge, United Kingdom, SE1 9RT | |
Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road | |
Tonbridge, United Kingdom, TN10 3ET | |
Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells | |
Kent, United Kingdom, TN 1 2DX | |
Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge | |
Wigan, United Kingdom, WN6 9EW | |
Synexus Birmingham Clinical Research Centre, Birmingham Research Park | |
Edgbaston, United Kingdom, B15 2SQ | |
Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens | |
Reading, United Kingdom, RG2 7AG | |
United Kingdom, Middlesex | |
Royal National Orthapaedic Hsopital, Brackley Hill | |
Stanmore, Middlesex, United Kingdom, HA 7 4LP | |
95 Stanwell Road | |
Ashford, Middlesex, United Kingdom, TW15 3EA | |
United Kingdom, SE17EH | |
St Thomas Hospital, Lambeth Place Road | |
London, SE17EH, United Kingdom | |
United Kingdom, Surrey | |
The Medical Centre, Kingston Avenue | |
East Horsley, Surrey, United Kingdom, KT24 6QT | |
The Crouch Oak Practice, 45 Station Road, Addlestone | |
Addlestone, Surrey, United Kingdom, KT15 2BH | |
United Kingdom, Warwickshire | |
Bridge House Medical Centre, Scholars Lane | |
Stratford-upon-avon, Warwickshire, United Kingdom, CV37 6HE | |
United Kingdom, West Sussex | |
Pound Hill Surgery, 1 Crawley Lane, Pound Hill | |
Crawley, West Sussex, United Kingdom, RH10 7DX |
Study Director: | John Beary, MD | Procter and Gamble |
Responsible Party: | Procter and Gamble Pharmaceuticals ( John Beary, MD ) |
Study ID Numbers: | 2001065 |
Study First Received: | July 16, 2002 |
Last Updated: | February 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00041756 |
Health Authority: | United States: Food and Drug Administration |
Primary Disease: Knee Primary Osteoarthritis |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |