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:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | ABT-712 | Hydrocodone/Acetaminophen | Placebo |
---|---|---|---|
![]() |
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 |
Baseline Characteristics
Arm/Group Title | ABT-712 | Hydrocodone/Acetaminophen | Placebo | Total | |
---|---|---|---|---|---|
![]() |
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 | |
![]() |
[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%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Global Medical Services |
Organization: | AbbVie (prior sponsor, Abbott) |
Phone: | 800-633-9110 |
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 |