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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PG-530742
Placebo
50 mg PG-530742
100 mg PG-530742
200 mg PG-530742
Sponsored by
Procter and Gamble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Primary Disease: Knee Primary Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rehabilitation Hospital, Gizella telep
  • Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
  • National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40
  • National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40
  • National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40
  • Orthopedic Clinic, Karolina ut 17
  • Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.
  • 95 Stanwell Road
  • Royal National Orthapaedic Hsopital, Brackley Hill
  • St Thomas Hospital, Lambeth Place Road
  • The Crouch Oak Practice, 45 Station Road, Addlestone
  • The Medical Centre, Kingston Avenue
  • Bridge House Medical Centre, Scholars Lane
  • Pound Hill Surgery, 1 Crawley Lane, Pound Hill
  • Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak
  • Synexus Birmingham Clinical Research Centre, Birmingham Research Park
  • Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells
  • Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
  • Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road
  • Dept of Rheumatology Dulwich Hospital, East Dulwich
  • Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens
  • Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road
  • Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

25 mg PG-530742

50 mg PG-530742

100 mg PG-530742

200 mg PG-530742

Arm Description

Placebo tablet

25 mg PG-530742

50 mg PG-530742

100 mg PG-530742

200 mg PG-530742

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

Full Information

First Posted
July 16, 2002
Last Updated
November 7, 2011
Sponsor
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT00041756
Brief Title
Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
Official Title
Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Primary Disease: Knee Primary Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
395 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet
Arm Title
25 mg PG-530742
Arm Type
Experimental
Arm Description
25 mg PG-530742
Arm Title
50 mg PG-530742
Arm Type
Experimental
Arm Description
50 mg PG-530742
Arm Title
100 mg PG-530742
Arm Type
Experimental
Arm Description
100 mg PG-530742
Arm Title
200 mg PG-530742
Arm Type
Experimental
Arm Description
200 mg PG-530742
Intervention Type
Drug
Intervention Name(s)
PG-530742
Intervention Description
One 25 mg PG-530742 tablet, twice daily for for one year
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One placebo tablet, twice daily for for one year
Intervention Type
Drug
Intervention Name(s)
50 mg PG-530742
Intervention Description
One 50 mg PG-530742 tablet, twice daily for for one year
Intervention Type
Drug
Intervention Name(s)
100 mg PG-530742
Intervention Description
100 mg PG-530742 tablet, twice a day for one year
Intervention Type
Drug
Intervention Name(s)
200 mg PG-530742
Intervention Description
200 mg PG-530742 tablet, twice a day for one year
Primary Outcome Measure Information:
Title
Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment
Description
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.
Time Frame
baseline and 12 months
Title
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year
Description
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)
Time Frame
baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Beary, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Rehabilitation Hospital, Gizella telep
City
Visegrad
State/Province
Gizella telep
ZIP/Postal Code
2026
Country
Hungary
Facility Name
Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
City
Gyor
State/Province
Hid Utica 2
ZIP/Postal Code
9025
Country
Hungary
Facility Name
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Orthopedic Clinic, Karolina ut 17
City
Budapest
ZIP/Postal Code
1113
Country
Hungary
Facility Name
Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
95 Stanwell Road
City
Ashford
State/Province
Middlesex
ZIP/Postal Code
TW15 3EA
Country
United Kingdom
Facility Name
Royal National Orthapaedic Hsopital, Brackley Hill
City
Stanmore
State/Province
Middlesex
ZIP/Postal Code
HA 7 4LP
Country
United Kingdom
Facility Name
St Thomas Hospital, Lambeth Place Road
City
London
State/Province
Se17eh
Country
United Kingdom
Facility Name
The Crouch Oak Practice, 45 Station Road, Addlestone
City
Addlestone
State/Province
Surrey
ZIP/Postal Code
KT15 2BH
Country
United Kingdom
Facility Name
The Medical Centre, Kingston Avenue
City
East Horsley
State/Province
Surrey
ZIP/Postal Code
KT24 6QT
Country
United Kingdom
Facility Name
Bridge House Medical Centre, Scholars Lane
City
Stratford-upon-avon
State/Province
Warwickshire
ZIP/Postal Code
CV37 6HE
Country
United Kingdom
Facility Name
Pound Hill Surgery, 1 Crawley Lane, Pound Hill
City
Crawley
State/Province
West Sussex
ZIP/Postal Code
RH10 7DX
Country
United Kingdom
Facility Name
Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak
City
Birmingham
ZIP/Postal Code
B29 6JD
Country
United Kingdom
Facility Name
Synexus Birmingham Clinical Research Centre, Birmingham Research Park
City
Edgbaston
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells
City
Kent
ZIP/Postal Code
TN 1 2DX
Country
United Kingdom
Facility Name
Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
City
London Bridge
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Dept of Rheumatology Dulwich Hospital, East Dulwich
City
London
ZIP/Postal Code
SE22 8PT
Country
United Kingdom
Facility Name
Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens
City
Reading
ZIP/Postal Code
RG2 7AG
Country
United Kingdom
Facility Name
Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road
City
Tonbridge
ZIP/Postal Code
TN10 3ET
Country
United Kingdom
Facility Name
Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge
City
Wigan
ZIP/Postal Code
WN6 9EW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17958901
Citation
Krzeski P, Buckland-Wright C, Balint G, Cline GA, Stoner K, Lyon R, Beary J, Aronstein WS, Spector TD. Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study. Arthritis Res Ther. 2007;9(5):R109. doi: 10.1186/ar2315.
Results Reference
derived

Learn more about this trial

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

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