Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

ABT-712 Extended-release

Intervention Type DRUG

ABT-712 extended-release tablet

Placebo

Intervention Type DRUG

Placebo tablet

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).

Group Type ACTIVE_COMPARATOR

Hydrocodone/Acetaminophen Immediate-release

Intervention Type DRUG

Hydrocodone/acetaminophen immediate-release tablet

Placebo

Intervention Type DRUG

Placebo tablet

Placebo

2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet

Interventions

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ABT-712 Extended-release

ABT-712 extended-release tablet

Intervention Type DRUG

Hydrocodone/Acetaminophen Immediate-release

Hydrocodone/acetaminophen immediate-release tablet

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type DRUG

Other Intervention Names

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Hydrocodone/acetaminophen extended-release Hydrocodone bitartrate and acetaminophen extended-release

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No