A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee

Stopped early · Phase 2

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT00396955

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

560

Starts

2006-11-01

Expected to finish

2007-11-01

Last updated by the study team

2007-12-28

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Palo Alto, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Santa Maria, California, United States
• Study site — Upland, California, United States
• Study site — Delray Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Frederick, Maryland, United States
• Study site — Fall River, Massachusetts, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Dover, New Hampshire, United States
• Study site — Mamaroneck, New York, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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