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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00041756
First received: July 16, 2002
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 395
Study Start Date: July 2002
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 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
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
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
Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
London Bridge, United Kingdom, SE1 9RT
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
  More Information

No publications provided by Procter and Gamble

Additional 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
Study First Received: July 16, 2002
Results First Received: August 3, 2011
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014