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Completed

NCT Number: NCT00041756

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rehabilitation Hospital, Gizella telep, Visegrád, Gizella Telep, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PG-530742

Drug

One 25 mg PG-530742 tablet, twice daily for for one year

Placebo

Drug

One placebo tablet, twice daily for for one year

50 mg PG-530742

Drug

One 50 mg PG-530742 tablet, twice daily for for one year

100 mg PG-530742

Drug

100 mg PG-530742 tablet, twice a day for one year

200 mg PG-530742

Drug

200 mg PG-530742 tablet, twice a day for one year

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jul 17, 2002
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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