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

• Osteoarthritis
• Chronic Pain

• Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
  
  capsules, up to 80 mg bid
  Other Name: Embeda
• Drug: Placebo
  
  capsules, bid

• Experimental: ALO-01
  
  Up to 80 mg twice a day (bid)
  Intervention: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
• Placebo Comparator: Placebo
  
  Twice a day (bid)
  Intervention: Drug: Placebo

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