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

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydrocodone/Acetaminophen Extended-Release
Hydrocodone/Acetaminophen Extended Release
Placebo
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Acute pain following bunionectomy surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Ref # / Investigator 2589
  • Site Ref # / Investigator 2587
  • Site Ref # / Investigator 2586
  • Site Ref # / Investigator 2588
  • Site Ref # / Investigator 2585

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1: hydrocodone / acetaminophen extended release

Arm 2: hydrocodone / acetaminophen extended release

Arm 3: Placebo

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Time-interval weighted sum of pain relief (TOTPAR)
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
Perceptible pain relief
Meaningful pain relief
Pain relief (PR)
Pain intensity (PI)

Full Information

First Posted
November 20, 2006
Last Updated
January 24, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00402792
Brief Title
A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Acute pain following bunionectomy surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: hydrocodone / acetaminophen extended release
Arm Type
Experimental
Arm Title
Arm 2: hydrocodone / acetaminophen extended release
Arm Type
Experimental
Arm Title
Arm 3: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hydrocodone/Acetaminophen Extended-Release
Other Intervention Name(s)
ABT-712, hydrocodone / acetaminophen extended release
Intervention Description
1 tablet q 12 hours
Intervention Type
Drug
Intervention Name(s)
Hydrocodone/Acetaminophen Extended Release
Other Intervention Name(s)
ABT-712, hydrocodone / acetaminophen extended release
Intervention Description
2 tablets q 12 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 tablets q 12 hours
Primary Outcome Measure Information:
Title
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.
Description
Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Time-interval weighted sum of pain relief (TOTPAR)
Time Frame
12 hours
Title
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
Time Frame
12 hours
Title
Perceptible pain relief
Time Frame
12 hours
Title
Meaningful pain relief
Time Frame
12 hours
Title
Pain relief (PR)
Time Frame
12 hours
Title
Pain intensity (PI)
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Jain, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Ref # / Investigator 2589
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Site Ref # / Investigator 2587
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Site Ref # / Investigator 2586
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Ref # / Investigator 2588
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Site Ref # / Investigator 2585
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84094
Country
United States

12. IPD Sharing Statement

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

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