A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.

Inclusion criteria

• Subject is 21 years of age or older
• Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential
• Negative pregnancy test if female of childbearing potential
• Subject is in general good health
• Subject required treatment of joint pain within the last 90 days
• Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee

Exclusion criteria

• Subject has a documented history of allergic reaction or intolerance to morphine or other opioids
• Subject is pregnant or breast-feeding
• Subject is receiving systemic chemotherapy
• Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence
• Subject has history of major depressive disorder not controlled with medication
• Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA
• Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD)
• Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis