A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with
 placebo for treating moderate to severe chronic pain over a 12 week period.
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