Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain

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 the past 2 years, with the exception of
basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.