Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee

Inclusion Criteria: * Clinical diagnosis of OA of the knee according to the ACR criteria. * Kellgren-Lawrence grade 2-3 disease * Be willing to stop taking all analgesics including NSAIDs and opioids for the duration of the study, with exception of study-specified rescue medication. Exclusion Criteria: * Total knee replacement surgery tentatively scheduled within next 6 months. * Palpable knee effusion. * Significant pain outside the target knee, including significant hip, back, or contralateral knee pain. * Any type of orthopedic and/or prosthetic device or any skin abnormalities on the target knee that would prevent evaluations of local tolerability. * History of asthma, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis), or fibromyalgia. * History of gastrointestinal bleeding or peptic ulcer disease within the past 3 years. * Have a positive urine drug test for illegal drug substances, non-prescribed controlled substances, or alcohol at screening. * Acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study.