NCT00402792

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Hydrocodone/Acetaminophen Extended-Release	1 tablet q 12 hours
DRUG	Hydrocodone/Acetaminophen Extended Release	2 tablets q 12 hours
DRUG	Placebo	2 tablets q 12 hours

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2006-11-22
• Last updated: 2011-01-25

Locations

5 sites across 1 country: United States