Clinical Research Directory

Inclusion Criteria: * Males or females 18 years of age or older * Diagnosis of osteoarthritis of the knee (unilateral or bilateral) * Meet pain entry criteria * Willing to discontinue use of all analgesic medications (including over-the-counter \[OTC\] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes. Exclusion Criteria: * Positive urine pregnancy test, pregnant or lactating. * Have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or Paget's disease * Have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee * Have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit * Have a history or physical examination finding that is incompatible with safe participation in the study or study product use * Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions. * Have significant renal or hepatic impairment * Are taking a sleep medication at a dose that has not been stable for at least 3 months