Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.

The primary efficacy objective of this study is to compare the time to emergence of inadequate analgesia of 8 mg Hydromorphone Hydrochloride Extended-Release taken once every 24 hours versus placebo in the treatment of patients with persistent pain who require an opioid medication for control of their pain.

Inclusion Criteria:

• persistent, moderate-to-severe noncancer related pain requiring continuous analgesia for weeks to months, or longer, who are currently taking 20 to 40 mg of oxycodone or opioid equivalents per day for control of their persistent pain and who are willing to accept the possibility of receiving placebo during the Double-Blind Phase

Exclusion Criteria:

• Patients already receiving opioid medication at an average total daily dose greater than 40 mg of oxycodone or opioid equivalents during the last week prior to study entry.

Other protocol-specific exclusion/inclusion criteria may apply.