Acute Pain Study Following Bunionectomy

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone

Criteria

Inclusion Criteria:

Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy

Exclusion Criteria:

• Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures

• Drug allergies to hydrocodone, acetaminophen

• Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction