- Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray
- Documented history that subject tried the following medications and had insufficient
pain relief or is cannot take or tolerate them: acetaminophen, NSAIDs and either
tramadol or opioids
- Meet the protocol requirements for pain at screening and pain, physical function and
patient global assessment of osteoarthritis at baseline
- Willing to discontinue all pain medications except study medication and rescue
medication during the course of the study and use those as directed per protocol
- Women able to have children must agree to use 2 forms of contraception during the
study
- Body Mass Index (BMI) greater than 39
- History of diseases other than osteoarthritis in a shoulder, hip or knee (example,
rheumatoid arthritis, gout, joint infections, osteonecrosis)
- Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or
certain types of fractures
- Patients who have had significant trauma or surgery to a knee, hip or shoulder within
the previous year
- Planned surgical procedure during the study
- Patients who are largely or wholly incapacitated (example bedridden or confined to a
wheelchair, permitting little or no self-care)
- Patients who would be unwilling or unable to undergo joint replacement surgery if one
eventually became necessary
- Patients with significant conditions other than osteoarthritis that could interfere
with assessment of pain in the joints (example fibromyalgia, lupus erythematosus)
- Patients with significant heart, neurological or psychiatric diseases
- Patients who had cancer other than certain skin cancers within the past 5 years
- Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2
years
- Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed
during the course of the study.