NCT00404391

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

A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (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 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.

Conditions

• Pain

Interventions

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

Timeline

• Start date: 2003-10-01
• Primary completion: 2004-03-01
• Completion: 2004-03-01
• First posted: 2006-11-28
• Last updated: 2011-01-19

Locations

4 sites across 1 country: United States