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Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00935311
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : March 7, 2014
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: ABT-712 Extended-release
Drug: Hydrocodone/Acetaminophen Immediate-release
Drug: Placebo
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ABT-712 Hydrocodone/Acetaminophen Placebo
Hide Arm/Group 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).
Period Title: Overall Study
Started 43 39 40
Completed 43 39 40
Not Completed 0 0 0
Arm/Group Title ABT-712 Hydrocodone/Acetaminophen Placebo Total
Hide Arm/Group 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). Total of all reporting groups
Overall Number of Baseline Participants 43 39 40 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 39 participants 40 participants 122 participants
22.1  (2.83) 21.4  (3.20) 23.0  (4.73) 22.2  (3.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 39 participants 40 participants 122 participants
Female
22
  51.2%
23
  59.0%
28
  70.0%
73
  59.8%
Male
21
  48.8%
16
  41.0%
12
  30.0%
49
  40.2%
1.Primary Outcome
Title Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title ABT-712 Hydrocodone/Acetaminophen Placebo
Hide Arm/Group 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).
Overall Number of Participants Analyzed 43 39 40
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
268.8  (44.29) 230.9  (47.03) 54.8  (46.19)
2.Secondary Outcome
Title TOTPAR (Total Pain Relief)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title ABT-712 Hydrocodone/Acetaminophen Placebo
Hide Arm/Group 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).
Overall Number of Participants Analyzed 43 39 40
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
18.0  (2.06) 15.9  (2.16) 10.5  (2.13)
3.Secondary Outcome
Title Time to First Rescue Medication
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title ABT-712 Hydrocodone/Acetaminophen Placebo
Hide Arm/Group 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).
Overall Number of Participants Analyzed 43 39 40
Median (95% Confidence Interval)
Unit of Measure: minutes
442.0
(196.0 to 612.0)
205.0
(190.0 to 642.0)
123.5
(104.0 to 153.0)
4.Secondary Outcome
Title Participants With Adverse Events (AEs)
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title ABT-712 Hydrocodone/Acetaminophen Placebo
Hide Arm/Group 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).
Overall Number of Participants Analyzed 43 39 40
Measure Type: Number
Unit of Measure: participants
Any AE 14 12 14
Any AE at least "possibly" drug related 5 8 4
Any AE at least "probably not" drug related 9 4 10
Any "severe" AE 1 0 2
Any SAE 0 0 0
Any AE leading to discontinuation of study drug 0 0 0
Any AE leading to death 0 0 0
Death 0 0 0
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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ABT-712 Hydrocodone/Acetaminophen Placebo
Hide Arm/Group 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).
All-Cause Mortality
ABT-712 Hydrocodone/Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
ABT-712 Hydrocodone/Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/39 (0.00%)   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABT-712 Hydrocodone/Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/43 (25.58%)   10/39 (25.64%)   13/40 (32.50%) 
Gastrointestinal disorders       
DIARRHOEA † 1  0/43 (0.00%)  0/39 (0.00%)  2/40 (5.00%) 
NAUSEA † 1  7/43 (16.28%)  7/39 (17.95%)  2/40 (5.00%) 
VOMITING † 1  1/43 (2.33%)  2/39 (5.13%)  2/40 (5.00%) 
General disorders       
CHILLS † 1  0/43 (0.00%)  0/39 (0.00%)  2/40 (5.00%) 
Nervous system disorders       
DIZZINESS † 1  1/43 (2.33%)  5/39 (12.82%)  3/40 (7.50%) 
HEADACHE † 1  5/43 (11.63%)  0/39 (0.00%)  6/40 (15.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 12.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00935311    
Other Study ID Numbers: M11-063
First Submitted: June 29, 2009
First Posted: July 9, 2009
Results First Submitted: November 1, 2013
Results First Posted: March 7, 2014
Last Update Posted: April 8, 2014