Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
A Randomized, Multicenter, Single-blind, Placebo-controlled Study Comparing the Analgesic Efficacy and Safety of Hydrocodone/ Acetaminophen Extended-release Tablets and Hydrocodone/Acetaminophen (NORCO) to Placebo in Subjects With Acute Pain Following Third Molar Tooth Extraction
1 other identifier
interventional
122
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pain
Started Jun 2009
Shorter than P25 for phase_2 pain
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
March 7, 2014
CompletedApril 8, 2014
March 1, 2014
2 months
June 29, 2009
November 1, 2013
March 10, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
From time of first study drug administration to 12 hours following first study drug administration
Secondary Outcomes (3)
TOTPAR (Total Pain Relief)
From time of first study drug administration to 12 hours following first study drug administration
Time to First Rescue Medication
From time of first study drug administration to 12 hours following first study drug administration
Participants With Adverse Events (AEs)
AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).
Study Arms (3)
ABT-712
EXPERIMENTAL1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
Hydrocodone/Acetaminophen
ACTIVE COMPARATOR2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
Placebo
PLACEBO COMPARATOR2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
Interventions
ABT-712 extended-release tablet
Hydrocodone/acetaminophen immediate-release tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Site Reference ID/Investigator# 20745
Austin, Texas, 78705, United States
Site Reference ID/Investigator# 20743
San Marcos, Texas, 78666, United States
Site Reference ID/Investigator# 20744
Salt Lake City, Utah, 84117, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie (prior sponsor, Abbott)
Study Officials
- STUDY DIRECTOR
Pedro Quintana Diez, MD
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
July 9, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
April 8, 2014
Results First Posted
March 7, 2014
Record last verified: 2014-03