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

November 7, 2011 updated by: Procter and Gamble
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

395

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • 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
        • National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40
      • Budapest, Hungary, 1113
        • Orthopedic Clinic, Karolina ut 17
      • Miskolc, Hungary, 3529
        • Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.
    • Gizella telep
      • Visegrad, Gizella telep, Hungary, 2026
        • Rehabilitation Hospital, Gizella telep
    • Hid Utica 2
      • Gyor, Hid Utica 2, Hungary, 9025
        • Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
  • United Kingdom
      • Birmingham, United Kingdom, B29 6JD
        • Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak
      • Edgbaston, United Kingdom, B15 2SQ
        • Synexus Birmingham Clinical Research Centre, Birmingham Research Park
      • Kent, United Kingdom, TN 1 2DX
        • Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells
      • London, United Kingdom, E11 1NR
        • Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road
      • London, United Kingdom, SE22 8PT
        • Dept of Rheumatology Dulwich Hospital, East Dulwich
      • London Bridge, United Kingdom, SE1 9RT
        • Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
      • Reading, United Kingdom, RG2 7AG
        • Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens
      • Tonbridge, United Kingdom, TN10 3ET
        • Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road
      • Wigan, United Kingdom, WN6 9EW
        • Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge
    • Middlesex
      • Ashford, Middlesex, United Kingdom, TW15 3EA
        • 95 Stanwell Road
      • Stanmore, Middlesex, United Kingdom, HA 7 4LP
        • Royal National Orthapaedic Hsopital, Brackley Hill
    • Se17eh
      • London, Se17eh, United Kingdom
        • St Thomas Hospital, Lambeth Place Road
    • Surrey
      • Addlestone, Surrey, United Kingdom, KT15 2BH
        • The Crouch Oak Practice, 45 Station Road, Addlestone
      • East Horsley, Surrey, United Kingdom, KT24 6QT
        • The Medical Centre, Kingston Avenue
    • Warwickshire
      • Stratford-upon-avon, Warwickshire, United Kingdom, CV37 6HE
        • Bridge House Medical Centre, Scholars Lane
    • West Sussex
      • Crawley, West Sussex, United Kingdom, RH10 7DX
        • Pound Hill Surgery, 1 Crawley Lane, Pound Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 12 months
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)
baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Investigators

  • Study Director: John Beary, MD, Procter and Gamble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

July 16, 2002

First Submitted That Met QC Criteria

July 16, 2002

First Posted (Estimate)

July 17, 2002

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Knee

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe