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

Study Identifier
M05-772
CT.gov Identifier
NCT00404222
EudraCT Identifier
Not available
EUCTIS ID
Not available
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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 Immediate Release (NORCO®)
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion 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.

    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 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.

    Study Locations

    No locations found.