NCT00404222

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (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 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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Hydrocodone/Acetaminophen Extended-Release	2 tablets x 1
DRUG	Hydrocodone/Acetaminophen Immediate Release (NORCO®)	1 tablet q 4 hours x 3
DRUG	Placebo	q 4 hours x 3

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2006-11-28
• Last updated: 2011-07-25