Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

Study Identifier
M12-058
CT.gov Identifier
NCT01038609
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
  • Acetaminophen
  • Morphine 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 surgery and who were willing to remain confined for approximately 4 days following surgery for study procedures.
    Exclusion Criteria:
    * Subjects who underwent Base wedge osteotomy and/or Long-Z hart bunionectomy procedures * Allergic reaction to study medications * Pregnant or breastfeeding females * Clinically significant lab abnormalities at screening * Positive hepatitis testing at screening * Clinically significant or uncontrolled medical disorders or illness at screening * Active malignancy or chemotherapy * Any history of drug or alcohol abuse/addiction * Known or suspected history of human immunodeficiency virus (HIV); requires treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) or butyrophenones * History of major depressive episode or major psychiatric disorder * Current systemic corticosteroid therapy * Inability to refrain from smoking during or alcohol during stay at investigative site

    Protocol Summary

    The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 26223
    Peoria, Arizona, United States, 85381
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 26302
    Austin, Texas, United States, 78705
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 26303
    San Marcos, Texas, United States, 78666
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 26304
    West Jordan, Utah, United States, 84088
    Status
    Not applicable