A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402792
• Other study ID #: M05-765
• Status: Completed
• Phase: Phase 3
• First received: November 20, 2006
• Last updated: January 24, 2011
• Start date: December 2006
• Est. completion date: April 2007

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and females ages 18 to 65

• Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery

• Meet specific pain intensity criteria on the morning after surgery

• Willing to be confined for 4 days following surgery

• If female, must be of non-child bearing potential or practicing birth control

Exclusion Criteria:

• Is allergic to or has a serious reaction to hydrocodone, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs

• Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)

• Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract

• Has specific active or uncontrolled seizure disorders

• Has been diagnosed with certain cancers within the past 5 years

• Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression

• Has specific clinically significant illnesses or laboratory abnormalities

• Has received corticosteroid treatment or any investigational drug within a specific timeframe

Study Design

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

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Site Ref # / Investigator 2589	Austin	Texas
United States	Site Ref # / Investigator 2587	Houston	Texas
United States	Site Ref # / Investigator 2585	Salt Lake City	Utah
United States	Site Ref # / Investigator 2586	San Antonio	Texas
United States	Site Ref # / Investigator 2588	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 intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration.	Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)	12 hours	No
Secondary	Time-interval weighted sum of pain relief (TOTPAR)		12 hours	No
Secondary	Time-interval weighted sum of pain relief and pain intensity difference (SPRID)		12 hours	No
Secondary	Perceptible pain relief		12 hours	No
Secondary	Meaningful pain relief		12 hours	No
Secondary	Pain relief (PR)		12 hours	No
Secondary	Pain intensity (PI)		12 hours	No