Conditions: Osteoarthritis Chronic Pain
Keywords: hip knee pain osteoarthritis OA Kadian Alpharma naltrexone Opioid morphine Embeda ALO-01
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 547
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Up to 80 mg twice a day (bid) arm 2: Twice a day (bid)

Interventions: intervention 1: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) intervention 2: Placebo
Intervention descriptions: intervention 1: capsules, up to 80 mg bid intervention 2: capsules, bid

Protocol document: