Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

Study Identifier
M11-063
CT.gov Identifier
NCT00935311
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
  • ABT-712 Extended-release
  • Hydrocodone/Acetaminophen Immediate-release
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subjects who are in general good health, experiencing moderate to severe pain after surgical extraction of 2 or more third molars and who are willing to remain confined until the morning after surgery for study procedures
    Exclusion Criteria:
    * Allergies to study medications * History of multiple drug allergies * Unable to stop excluded medications * Clinically significant laboratory abnormalities at Screening * Significant medical condition at Screening * Women who are pregnant or breast feeding

    Protocol Summary

    The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 20745
    Austin, Texas, United States, 78705
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 20743
    San Marcos, Texas, United States, 78666
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 20744
    Salt Lake City, Utah, United States, 84117
    Status
    Not applicable