Acute Pain Study Following Bunionectomy

March 10, 2014 updated by: AbbVie (prior sponsor, Abbott)

A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release to Placebo in Subjects With Acute Pain Following Bunionectomy

The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.

Study Overview

Status

Completed

Conditions

Detailed Description

The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.

After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.

Study Type

Interventional

Enrollment (Actual)

100

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

    • California
      • Pasadena, California, United States, 91105
        • Site Reference ID/Investigator# 51464
    • Texas
      • Austin, Texas, United States, 78705
        • Site Reference ID/Investigator# 51602
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Site Reference ID/Investigator# 51344

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy

Exclusion Criteria:

  • Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
  • Drug allergies to hydrocodone, acetaminophen
  • Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
placebo, 1 oral tablet every 12 hours
Placebo tablet
EXPERIMENTAL: Hydrocodone/Acetaminophen Extended Release
hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours
Other Names:
  • ABT-712

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
Time Frame: From time of first study drug administration to 12 hours following first study drug administration
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
From time of first study drug administration to 12 hours following first study drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Perceptible and Meaningful Pain Relief
Time Frame: From time of first study drug administration to 12 hours following first study drug administration
The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.
From time of first study drug administration to 12 hours following first study drug administration
TOTPAR (Total Pain Relief)
Time Frame: From time of first study drug administration to 12 hours following first study drug administration
TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
From time of first study drug administration to 12 hours following first study drug administration
SPRID (Pain Relief and Pain Intensity Difference)
Time Frame: From time of first study drug administration to 12 hours following first study drug administration
SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: "My pain at this time is…" with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
From time of first study drug administration to 12 hours following first study drug administration

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2011

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

April 11, 2011

First Posted (ESTIMATE)

April 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 8, 2014

Last Update Submitted That Met QC Criteria

March 10, 2014

Last Verified

March 1, 2014

More Information

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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