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A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

Primary Purpose

Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hydrocodone/Acetaminophen Extended-Release
Hydrocodone/Acetaminophen Immediate Release (NORCO®)
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

Eligibility Criteria

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

Inclusion Criteria:

  • Males and females ages 18 to 65
  • Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
  • Must meet specific pain intensity criteria on the morning after surgery
  • Willing to remain at the study center 2 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, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
  • Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
  • Has a history of or currently has any active seizure disorder
  • Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
  • Has been diagnosed with cancer within the past 3 years
  • Requires treatment with certain drugs for depression or psychiatric disorders
  • Has specific clinically significant illnesses or laboratory abnormalities
  • Received corticosteroid treatment or any investigational drug within a specific timeframe.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    hydrocodone / acetaminophen extended release

    Hydrocodone/Acetaminophen Immediate Release (Norco ®)

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration.
    Sum of Pain Intensity Difference using a 100mm 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)
    Time to first noticeable pain relief (i.e., onset of pain relief)
    Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)
    Proportion of subjects experiencing meaningful pain relief after dosing

    Full Information

    First Posted
    November 26, 2006
    Last Updated
    July 22, 2011
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00404222
    Brief Title
    A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
    Official Title
    A Randomized, Multicenter, Single-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) to Placebo in Subjects With Acute Pain Following Bunionectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    February 2006 (Actual)
    Study Completion Date
    February 2006 (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 and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, 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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    hydrocodone / acetaminophen extended release
    Arm Type
    Experimental
    Arm Title
    Hydrocodone/Acetaminophen Immediate Release (Norco ®)
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrocodone/Acetaminophen Extended-Release
    Other Intervention Name(s)
    hydrocodone / acetaminophen extended release
    Intervention Description
    2 tablets x 1
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrocodone/Acetaminophen Immediate Release (NORCO®)
    Intervention Description
    1 tablet q 4 hours x 3
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    q 4 hours x 3
    Primary Outcome Measure Information:
    Title
    The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration.
    Time Frame
    12 hours
    Title
    Sum of Pain Intensity Difference using a 100mm 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
    Time to first noticeable pain relief (i.e., onset of pain relief)
    Time Frame
    12 hours
    Title
    Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)
    Time Frame
    12 hours
    Title
    Proportion of subjects experiencing meaningful pain relief after dosing
    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 Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy) Must meet specific pain intensity criteria on the morning after surgery Willing to remain at the study center 2 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, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) Has a history of or currently has any active seizure disorder Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract Has been diagnosed with cancer within the past 3 years Requires treatment with certain drugs for depression or psychiatric disorders Has specific clinically significant illnesses or laboratory abnormalities 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

    12. IPD Sharing Statement

    Learn more about this trial

    A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

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