A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy

A Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) to Placebo in Subjects With Acute Pain Following Bunionectomy

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended-Release Hydrocodone/Acetaminophen compared to placebo over a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

Inclusion Criteria:

• Males and females ages 18 to 65
• Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
• Meet specific pain intensity criteria on the morning after surgery
• Willing to be confined for 4 days following surgery
• If female, must be of non-child bearing potential or practicing birth control

Exclusion Criteria:

• Is allergic to or has a serious reaction to hydrocodone, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs
• Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract
• Has specific active or uncontrolled seizure disorders
• Has been diagnosed with certain cancers within the past 5 years
• Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression
• Has specific clinically significant illnesses or laboratory abnormalities
• Has received corticosteroid treatment or any investigational drug within a specific timeframe