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

January 14, 2011 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 2

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
    • Maryland
      • Owing Mills, Maryland, United States, 21117
        • Site Ref # / Investigator 4993
    • Texas
      • Austin, Texas, United States, 78705
        • Site Ref # / Investigator 4994
      • San Marcos, Texas, United States, 78666
        • Site Ref # / Investigator 4992
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Site Ref # / Investigator 4995

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: placebo
Drug: Placebo
2 tablets every 12 hours
Experimental: Arm 1: hydrocodone/acetaminophen extended release
Drug: Hydrocodone/Acetaminophen Extended Release
1 tablet every 12 hours
Other Names:
  • ABT-712
Drug: Hydrocodone/Acetaminophen Extended Release
2 tablets every 12 hours
Other Names:
  • ABT-712
Experimental: Arm 2: hydrocodone/acetaminophen extended release
Drug: Hydrocodone/Acetaminophen Extended Release
1 tablet every 12 hours
Other Names:
  • ABT-712
Drug: Hydrocodone/Acetaminophen Extended Release
2 tablets every 12 hours
Other Names:
  • ABT-712

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration
Time Frame: 12 hours
Pain relief measured by a 100mm Visual Analog Scale (VAS)
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time interval weighted sum of pain intensity difference (SPID)scores
Time Frame: 12 hours
Sum of pain intensity difference
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

October 1, 2003

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

November 26, 2006

First Submitted That Met QC Criteria

November 26, 2006

First Posted (Estimate)

November 28, 2006

Study Record Updates

Last Update Posted (Estimate)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 14, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M03-609

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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