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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041756
• Other study ID #: 2001065
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2002
• Last updated: November 7, 2011
• Start date: July 2002
• Est. completion date: February 2004

Study information

• Verified date: November 2011
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• PG-530742
One 25 mg PG-530742 tablet, twice daily for for one year
• Placebo
One placebo tablet, twice daily for for one year
• 50 mg PG-530742
One 50 mg PG-530742 tablet, twice daily for for one year
• 100 mg PG-530742
100 mg PG-530742 tablet, twice a day for one year
• 200 mg PG-530742
200 mg PG-530742 tablet, twice a day for one year

Locations

Country	Name	City	State
Hungary	National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40	Budapest
Hungary	National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40	Budapest
Hungary	National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40	Budapest
Hungary	Orthopedic Clinic, Karolina ut 17	Budapest
Hungary	Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.	Gyor	Hid Utica 2
Hungary	Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.	Miskolc
Hungary	Rehabilitation Hospital, Gizella telep	Visegrad	Gizella telep
United Kingdom	The Crouch Oak Practice, 45 Station Road, Addlestone	Addlestone	Surrey
United Kingdom	95 Stanwell Road	Ashford	Middlesex
United Kingdom	Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak	Birmingham
United Kingdom	Pound Hill Surgery, 1 Crawley Lane, Pound Hill	Crawley	West Sussex
United Kingdom	The Medical Centre, Kingston Avenue	East Horsley	Surrey
United Kingdom	Synexus Birmingham Clinical Research Centre, Birmingham Research Park	Edgbaston
United Kingdom	Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells	Kent
United Kingdom	Dept of Rheumatology Dulwich Hospital, East Dulwich	London
United Kingdom	Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road	London
United Kingdom	St Thomas Hospital, Lambeth Place Road	London	Se17eh
United Kingdom	Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House	London Bridge
United Kingdom	Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens	Reading
United Kingdom	Royal National Orthapaedic Hsopital, Brackley Hill	Stanmore	Middlesex
United Kingdom	Bridge House Medical Centre, Scholars Lane	Stratford-upon-avon	Warwickshire
United Kingdom	Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road	Tonbridge
United Kingdom	Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge	Wigan

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Countries where clinical trial is conducted

Hungary,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No