Status:
COMPLETED
Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00935311
Start Date
June 1 2009
End Date
August 1 2009
Last Update
April 8 2014
Active Locations (3)
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1
Site Reference ID/Investigator# 20745
Austin, Texas, United States, 78705
2
Site Reference ID/Investigator# 20743
San Marcos, Texas, United States, 78666
3
Site Reference ID/Investigator# 20744
Salt Lake City, Utah, United States, 84117