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Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00041756
Recruitment Status : Completed
First Posted : July 17, 2002
Results First Posted : November 8, 2011
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: PG-530742 Drug: Placebo Drug: 50 mg PG-530742 Drug: 100 mg PG-530742 Drug: 200 mg PG-530742 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
Study Start Date : July 2002
Primary Completion Date : February 2004
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo tablet
Drug: Placebo
One placebo tablet, twice daily for for one year
Experimental: 25 mg PG-530742
25 mg PG-530742
Drug: PG-530742
One 25 mg PG-530742 tablet, twice daily for for one year
Experimental: 50 mg PG-530742
50 mg PG-530742
Drug: 50 mg PG-530742
One 50 mg PG-530742 tablet, twice daily for for one year
Experimental: 100 mg PG-530742
100 mg PG-530742
Drug: 100 mg PG-530742
100 mg PG-530742 tablet, twice a day for one year
Experimental: 200 mg PG-530742
200 mg PG-530742
Drug: 200 mg PG-530742
200 mg PG-530742 tablet, twice a day for one year



Primary Outcome Measures :
  1. Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment [ Time Frame: 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.

  2. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year [ Time Frame: 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)



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041756


Locations
Hungary
Rehabilitation Hospital, Gizella telep
Visegrad, Gizella telep, Hungary, 2026
Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
Gyor, Hid Utica 2, Hungary, 9025
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
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., 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
United Kingdom
95 Stanwell Road
Ashford, Middlesex, United Kingdom, TW15 3EA
Royal National Orthapaedic Hsopital, Brackley Hill
Stanmore, Middlesex, United Kingdom, HA 7 4LP
St Thomas Hospital, Lambeth Place Road
London, Se17eh, United Kingdom
The Crouch Oak Practice, 45 Station Road, Addlestone
Addlestone, Surrey, United Kingdom, KT15 2BH
The Medical Centre, Kingston Avenue
East Horsley, Surrey, United Kingdom, KT24 6QT
Bridge House Medical Centre, Scholars Lane
Stratford-upon-avon, Warwickshire, United Kingdom, CV37 6HE
Pound Hill Surgery, 1 Crawley Lane, Pound Hill
Crawley, West Sussex, United Kingdom, RH10 7DX
Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak
Birmingham, United Kingdom, B29 6JD
Synexus Birmingham Clinical Research Centre, Birmingham Research Park
Edgbaston, United Kingdom, B15 2SQ
Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells
Kent, United Kingdom, TN 1 2DX
Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
London Bridge, United Kingdom, SE1 9RT
Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road
London, United Kingdom, E11 1NR
Dept of Rheumatology Dulwich Hospital, East Dulwich
London, United Kingdom, SE22 8PT
Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens
Reading, United Kingdom, RG2 7AG
Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road
Tonbridge, United Kingdom, TN10 3ET
Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge
Wigan, United Kingdom, WN6 9EW
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: John Beary, MD Procter and Gamble

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00041756     History of Changes
Other Study ID Numbers: 2001065
First Posted: July 17, 2002    Key Record Dates
Results First Posted: November 8, 2011
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Procter and Gamble:
Primary Disease: Knee Primary Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases