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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
395

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Procter and Gamble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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