Osteoarthritis, KneePhase 2NCT00041756
Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
A Phase 2 study testing PG-530742, 50 mg PG-530742 and 100 mg PG-530742 in people with Osteoarthritis, Knee, run by Procter and Gamble at 23 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- PG-530742, 50 mg PG-530742 and 100 mg PG-530742
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 395 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Jul 2002to Feb 2004
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to moderate knee osteoarthritis confirmed by a radiographic technique.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United Kingdom16 sites
The Crouch Oak Practice, 45 Station Road, Addlestone
Addlestone, Surrey, KT15 2BH
95 Stanwell Road
Ashford, Middlesex, TW15 3EA
Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak
Birmingham, B29 6JD
Pound Hill Surgery, 1 Crawley Lane, Pound Hill
Crawley, West Sussex, RH10 7DX
The Medical Centre, Kingston Avenue
East Horsley, Surrey, KT24 6QT
Synexus Birmingham Clinical Research Centre, Birmingham Research Park
Edgbaston, B15 2SQ
Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells
Kent, TN 1 2DX
St Thomas Hospital, Lambeth Place Road
London, Se17eh
Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road
London, E11 1NR
Dept of Rheumatology Dulwich Hospital, East Dulwich
London, SE22 8PT
Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
London Bridge, SE1 9RT
Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens
Reading, RG2 7AG
Royal National Orthapaedic Hsopital, Brackley Hill
Stanmore, Middlesex, HA 7 4LP
Bridge House Medical Centre, Scholars Lane
Stratford-upon-Avon, Warwickshire, CV37 6HE
Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road
Tonbridge, TN10 3ET
Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge
Wigan, WN6 9EW
Hungary7 sites
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40
Budapest, 1027
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40
Budapest, 1027
National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40
Budapest, 1027
Orthopedic Clinic, Karolina ut 17
Budapest, 1113
Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
Győr, Hid Utica 2, 9025
Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.
Miskolc, 3529
Rehabilitation Hospital, Gizella telep
Visegrád, Gizella Telep, 2026
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- PG-530742, Placebo, 50 mg PG-530742, 100 mg PG-530742, 200 mg PG-530742
- Keywords
- Primary Disease: Knee Primary Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG-530742Drug
One 25 mg PG-530742 tablet, twice daily for for one year
PlaceboDrug
One placebo tablet, twice daily for for one year
50 mg PG-530742Drug
One 50 mg PG-530742 tablet, twice daily for for one year
100 mg PG-530742Drug
100 mg PG-530742 tablet, twice a day for one year
200 mg PG-530742Drug
200 mg PG-530742 tablet, twice a day for one year
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablet Receives: Drug: Placebo |
| 25 mg PG-530742 | Experimental | 25 mg PG-530742 Receives: Drug: PG-530742 |
| 50 mg PG-530742 | Experimental | 50 mg PG-530742 Receives: Drug: 50 mg PG-530742 |
| 100 mg PG-530742 | Experimental | 100 mg PG-530742 Receives: Drug: 100 mg PG-530742 |
| 200 mg PG-530742 | Experimental | 200 mg PG-530742 Receives: Drug: 200 mg PG-530742 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2002 (estimated)
- Study startJul 2002
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Beary, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041756
- Sponsor's protocol ID
- 2001065
- Status last verified
- Nov 2011
- First submitted
- 16 Jul 2002
- Last updated
- 8 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17958901
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00041756
- Acronym / sponsor ID
- 2001065
- Conditions
- Osteoarthritis, Knee
- Keywords
- Primary Disease: Knee Primary Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 17 Jul 2002 (estimated)
- Results
- Posted 8 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet |
| 25 mg PG-530742 | Experimental | Drug: PG-53074225 mg PG-530742 |
| 50 mg PG-530742 | Experimental | Drug: 50 mg PG-53074250 mg PG-530742 |
| 100 mg PG-530742 | Experimental | Drug: 100 mg PG-530742100 mg PG-530742 |
| 200 mg PG-530742 | Experimental | Drug: 200 mg PG-530742200 mg PG-530742 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild to moderate knee osteoarthritis confirmed by a radiographic technique.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG-530742One 25 mg PG-530742 tablet, twice daily for for one year | Drug | 25 mg PG-530742 |
| PlaceboOne placebo tablet, twice daily for for one year | Drug | Placebo |
| 50 mg PG-530742One 50 mg PG-530742 tablet, twice daily for for one year | Drug | 50 mg PG-530742 |
| 100 mg PG-530742100 mg PG-530742 tablet, twice a day for one year | Drug | 100 mg PG-530742 |
| 200 mg PG-530742200 mg PG-530742 tablet, twice a day for one year | Drug | 200 mg PG-530742 |
Primary outcome
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.
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 17958901Krzeski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Beary, MD study director
Procter and Gamble
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG-530742, 50 mg PG-530742 and 100 mg PG-530742 in people with Osteoarthritis, Knee, run by Procter and Gamble at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00041756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.