Acute Pain Study Following Bunionectomy

Study Identifier
M12-169
CT.gov Identifier
NCT01333722
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
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    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

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 51464
    Pasadena, California, United States, 91105
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51602
    Austin, Texas, United States, 78705
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51344
    Salt Lake City, Utah, United States, 84117
    Status
    Not applicable