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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone; Polystyrene sulfonic acid

Criteria

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