A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
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:
Exclusion Criteria include:
Other protocol specific inclusion/exclusion criteria may apply.