A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee
Status:
Terminated
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
Summary
Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active
osteoarthritis (OA) of the knee.
Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among
dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers
related to clinical responses. To assess PLA-695 exposure-response relationship on PD,
efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA.