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

Study Identifier
M05-765
CT.gov Identifier
NCT00402792
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Pain
    • Study Drug
  • Hydrocodone/Acetaminophen Extended-Release
  • Hydrocodone/Acetaminophen Extended Release
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Site Ref # / Investigator 2589
    Austin, Texas, United States, 78705
    Status
    Not applicable
    Location
    Site Ref # / Investigator 2587
    Houston, Texas, United States, 77081
    Status
    Not applicable
    Location
    Site Ref # / Investigator 2586
    San Antonio, Texas, United States, 78229
    Status
    Not applicable
    Location
    Site Ref # / Investigator 2588
    San Marcos, Texas, United States, 78666
    Status
    Not applicable
    Location
    Site Ref # / Investigator 2585
    Salt Lake City, Utah, United States, 84094
    Status
    Not applicable