A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release
 tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone
 controlled-release tablets (OXY) in subjects with moderate to severe low back pain and
 opioid-induced constipation who require around-the-clock opioid therapy.
Inclusion Criteria include:

 -  Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back
 pain (lasting at least several hours daily) as their predominant pain condition for at
 least 3 months prior to screening period;

 -  The low back pain must be related to nonmalignant and nonneuropathic conditions and
 may be with or without radiation;

 -  Subjects must have a self-reported history of opioid induced constipation (OIC).

 Exclusion Criteria include:

 -  Subjects with rheumatoid arthritis or other inflammatory arthritis;

 -  Subjects with neuropathic conditions that have been painful or required therapy within
 the past 3 months;

 -  Subjects with evidence of significant structural abnormalities of the gastrointestinal
 (GI) tract or other significant conditions affecting GI motility;

 -  Subjects with chronic constipation not related to opioid use;

 -  Subjects who had surgical procedures directed towards the source of chronic low back
 pain within 6 months of the screening visit or planned during the study;

 -  Subjects with a history of malignancy within past 2 years, with exception of basal
 cell carcinoma that has been successfully treated.

 Other protocol specific inclusion/exclusion criteria may apply.