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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404391
• Other study ID #: M03-609
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2006
• Last updated: January 14, 2011
• Start date: October 2003
• Est. completion date: March 2004

Study information

• Verified date: January 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Hydrocodone/Acetaminophen Extended Release
1 tablet every 12 hours
• Hydrocodone/Acetaminophen Extended Release
2 tablets every 12 hours
• Placebo
2 tablets every 12 hours

Locations

Country	Name	City	State
United States	Site Ref # / Investigator 4994	Austin	Texas
United States	Site Ref # / Investigator 4993	Owing Mills	Maryland
United States	Site Ref # / Investigator 4995	Salt Lake City	Utah
United States	Site Ref # / Investigator 4992	San Marcos	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration	Pain relief measured by a 100mm Visual Analog Scale (VAS)	12 hours	No
Secondary	Time interval weighted sum of pain intensity difference (SPID)scores	Sum of pain intensity difference	12 hours	No