Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
Primary Purpose
Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-712 Extended-release
Hydrocodone/Acetaminophen Immediate-release
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility 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
Sites / Locations
- Site Reference ID/Investigator# 20745
- Site Reference ID/Investigator# 20743
- Site Reference ID/Investigator# 20744
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
ABT-712
Hydrocodone/Acetaminophen
Placebo
Arm Description
1 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).
2 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).
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
TOTPAR (Total Pain Relief)
TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR 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.
Time to First Rescue Medication
The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.
Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
Full Information
NCT ID
NCT00935311
First Posted
June 29, 2009
Last Updated
March 10, 2014
Sponsor
AbbVie (prior sponsor, Abbott)
1. Study Identification
Unique Protocol Identification Number
NCT00935311
Brief Title
Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABT-712
Arm Type
Experimental
Arm Description
1 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).
Arm Title
Hydrocodone/Acetaminophen
Arm Type
Active Comparator
Arm Description
2 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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
Intervention Type
Drug
Intervention Name(s)
ABT-712 Extended-release
Other Intervention Name(s)
Hydrocodone/acetaminophen extended-release, Hydrocodone bitartrate and acetaminophen extended-release
Intervention Description
ABT-712 extended-release tablet
Intervention Type
Drug
Intervention Name(s)
Hydrocodone/Acetaminophen Immediate-release
Intervention Description
Hydrocodone/acetaminophen immediate-release tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
Description
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.
Time Frame
From time of first study drug administration to 12 hours following first study drug administration
Secondary Outcome Measure Information:
Title
TOTPAR (Total Pain Relief)
Description
TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR 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.
Time Frame
From time of first study drug administration to 12 hours following first study drug administration
Title
Time to First Rescue Medication
Description
The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.
Time Frame
From time of first study drug administration to 12 hours following first study drug administration
Title
Participants With Adverse Events (AEs)
Description
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
Time Frame
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Quintana Diez, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 20745
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Site Reference ID/Investigator# 20743
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Site Reference ID/Investigator# 20744
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
12. IPD Sharing Statement
Links:
URL
http://rxabbvie.com
Description
Related Info
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Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
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