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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: PG-530742
* Drug: Placebo
* Drug: 50 mg PG-530742
* Drug: 100 mg PG-530742
* Drug: 200 mg PG-530742


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo tablet | Drug: Placebo<br>* One placebo tablet, twice daily for for one year<br>|
| Experimental: 25 mg PG-530742<br>25 mg PG-530742 | Drug: PG-530742<br>* One 25 mg PG-530742 tablet, twice daily for for one year<br>|
| Experimental: 50 mg PG-530742<br>50 mg PG-530742 | Drug: 50 mg PG-530742<br>* One 50 mg PG-530742 tablet, twice daily for for one year<br>|
| Experimental: 100 mg PG-530742<br>100 mg PG-530742 | Drug: 100 mg PG-530742<br>* 100 mg PG-530742 tablet, twice a day for one year<br>|
| Experimental: 200 mg PG-530742<br>200 mg PG-530742 | Drug: 200 mg PG-530742<br>* 200 mg PG-530742 tablet, twice a day for one year<br>|

What is the study measuring?
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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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Disease: Knee Primary Osteoarthritis