Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
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.
Dosing started within 6 hours after completion of third molar extraction. Study drug was
 given once every 6 hours for 12 hours (for a total of 2 doses). Participants were randomized
 to receive placebo or active drug (either experimental drug or comparator). The total dose
 was the same for both groups receiving active drug, but was given as either 1 dose of
 extended-release tablets (experimental drug), or 2 doses of immediate-release tablets (active
 comparator).
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