- Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray
grade of 2.
- Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain
medications have not provided adequate pain relief or are candidates for knee
injections arthroplasty or replace surgery.
- Pain level and function levels as required by the protocol at Screening and Baseline.
- Willing to discontinue pain medications (acetaminophen will be permitted up to a
certain level) before and during the study.
- Must agree to the contraceptive requirements of the protocol if applicable.
- Must agree to the treatment plan, scheduled visits, and procedures of the protocol.
- Pregnancy or intent to become pregnant during the study
- BMI greater than 39
- other severe pain, significant cardiac, neurological or psychological conditions, or
above the protocol limits for laboratory and blood pressure results