Phase 2
N=395
Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT00041756 ↗Enrolled (actual)
395
Serious AEs
13.7%
Results posted
Nov 2011
Primary outcome: Primary: Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment — -0.1361; -0.0442; -0.2261; -0.2000 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PG-530742 (Drug); Placebo (Drug); 50 mg PG-530742 (Drug); 100 mg PG-530742 (Drug); 200 mg PG-530742 (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Feb 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment |
-0.1361; -0.0442; -0.2261; -0.2000; -0.1916 | — |
| PRIMARY Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year |
-9.1; -6.7; -10.0; -5.8; -9.3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00041756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.