Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT00935311

First received: June 29, 2009

Last updated: March 10, 2014

Last verified: March 2014

History of Changes

Results First Received: November 1, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Pain
Interventions:	Drug: ABT-712 Extended-release Drug: Hydrocodone/Acetaminophen Immediate-release Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
ABT-712	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).
Hydrocodone/Acetaminophen	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).
Placebo	2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).

Participant Flow: Overall Study

	ABT-712	Hydrocodone/Acetaminophen	Placebo
STARTED	43	39	40
COMPLETED	43	39	40
NOT COMPLETED	0	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
ABT-712	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).
Hydrocodone/Acetaminophen	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).
Placebo	2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
Total	Total of all reporting groups

Baseline Measures

	ABT-712	Hydrocodone/Acetaminophen	Placebo	Total
Number of Participants [units: participants]	43	39	40	122
Age [units: years] Mean ± Standard Deviation	22.1 ± 2.83	21.4 ± 3.20	23.0 ± 4.73	22.2 ± 3.70
Gender [units: participants]
Female	22	23	28	73
Male	21	16	12	49

Outcome Measures

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1. Primary:

Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ]

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2. Secondary:

TOTPAR (Total Pain Relief) [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ]

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3. Secondary:

Time to First Rescue Medication [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ]

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4. Secondary:

Participants With Adverse Events (AEs) [ 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). ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT00935311 History of Changes
Other Study ID Numbers:	M11-063
Study First Received:	June 29, 2009
Results First Received:	November 1, 2013
Last Updated:	March 10, 2014
Health Authority:	United States: Food and Drug Administration

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