Clinical Trial: Efficacy and Safety of PG-530742 in the treatment of Mild to Moderate Knee Osteoarthritis

This study has been completed.

Sponsored by: Procter & Gamble Pharmaceuticals
Information provided by: Procter & Gamble Pharmaceuticals

Purpose

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 Treatment or Intervention Phase
Osteoarthritis, Knee
 Drug: PG-530742
Phase II

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  375

Study start: June 2002

Eligibility

Ages Eligible for Study:  40 Years   -   80 Years,  Genders Eligible for Study:  Both

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.

Location Information


Hungary
      National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40, Budapest,  1027,  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

      Orthopedic Clinic, Karolina ut 17, Budapest,  1113,  Hungary

      Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42., Miskolc,  3529,  Hungary

Hungary, Gizella telep
      Rehabilitation Hospital, Gizella telep, Visegrad,  Gizella telep,  2026,  Hungary

Hungary, Hid Utica 2
      Petz A. Country Hospital, Department of Rheumatology, Hid utca 2., Gyor,  Hid Utica 2,  9025,  Hungary

United Kingdom
      Dept of Rheumatology Dulwich Hospital, East Dulwich, London,  SE22 8PT,  United Kingdom

      Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road, London,  E11 1NR,  United Kingdom

      Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak, Birmingham,  B29 6JD,  United Kingdom

      Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House, London Bridge,  SE1 9RT,  United Kingdom

      Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road, Tonbridge,  TN10 3ET,  United Kingdom

      Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells, Kent,  TN 1 2DX,  United Kingdom

      Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge, Wigan,  WN6 9EW,  United Kingdom

      Synexus Birmingham Clinical Research Centre, Birmingham Research Park, Edgbaston,  B15 2SQ,  United Kingdom

      Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens, Reading,  RG2 7AG,  United Kingdom

United Kingdom, Middlesex
      Royal National Orthapaedic Hsopital, Brackley Hill, Stanmore,  Middlesex,  HA 7 4LP,  United Kingdom

      95 Stanwell Road, Ashford,  Middlesex,  TW15 3EA,  United Kingdom

United Kingdom, SE17EH
      St Thomas Hospital, Lambeth Place Road, London,  SE17EH,  United Kingdom

United Kingdom, Surrey
      The Medical Centre, Kingston Avenue, East Horsley,  Surrey,  KT24 6QT,  United Kingdom

      The Crouch Oak Practice, 45 Station Road, Addlestone, Addlestone,  Surrey,  KT15 2BH,  United Kingdom

United Kingdom, Warwickshire
      Bridge House Medical Centre, Scholars Lane, Stratford-upon-Avon,  Warwickshire,  CV37 6HE,  United Kingdom

United Kingdom, West Sussex
      Pound Hill Surgery, 1 Crawley Lane, Pound Hill, Crawley,  West Sussex,  RH10 7DX,  United Kingdom

More Information

Study ID Numbers:  2001065
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  July 16, 2002
ClinicalTrials.gov Identifier:  NCT00041756
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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