A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

• Status: Completed
• Trial end date: 2004-03-01
• 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 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with 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 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male or female ages 18 to 65

• Females must be of non-childbearing potential or practicing birth control

• Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery

Exclusion Criteria:

• Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs

• Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study

• Is associated with any currently ongoing research study