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

January 24, 2011 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78705
        • Site Ref # / Investigator 2589
      • Houston, Texas, United States, 77081
        • Site Ref # / Investigator 2587
      • San Antonio, Texas, United States, 78229
        • Site Ref # / Investigator 2586
      • San Marcos, Texas, United States, 78666
        • Site Ref # / Investigator 2588
    • Utah
      • Salt Lake City, Utah, United States, 84094
        • Site Ref # / Investigator 2585

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 3: Placebo
Drug: Placebo
2 tablets q 12 hours
Experimental: Arm 1: hydrocodone / acetaminophen extended release
Drug: Hydrocodone/Acetaminophen Extended-Release
1 tablet q 12 hours
Other Names:
  • ABT-712
  • hydrocodone / acetaminophen extended release
Experimental: Arm 2: hydrocodone / acetaminophen extended release
Drug: Hydrocodone/Acetaminophen Extended Release
2 tablets q 12 hours
Other Names:
  • ABT-712
  • hydrocodone / acetaminophen extended release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 hours
Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)
12 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time-interval weighted sum of pain relief (TOTPAR)
Time Frame: 12 hours
12 hours
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
Time Frame: 12 hours
12 hours
Perceptible pain relief
Time Frame: 12 hours
12 hours
Meaningful pain relief
Time Frame: 12 hours
12 hours
Pain relief (PR)
Time Frame: 12 hours
12 hours
Pain intensity (PI)
Time Frame: 12 hours
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M05-765

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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