A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

A Randomized, Multicenter, Single-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) 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 and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, 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
• Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
• Must meet specific pain intensity criteria on the morning after surgery
• Willing to remain at the study center 2 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, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
• Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Has a history of or currently has any active seizure disorder
• Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
• Has been diagnosed with cancer within the past 3 years
• Requires treatment with certain drugs for depression or psychiatric disorders
• Has specific clinically significant illnesses or laboratory abnormalities
• Received corticosteroid treatment or any investigational drug within a specific timeframe.