Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

AbbVie

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Placebo; Drug: Hydrocodone/Acetaminophen Immediate-release; Drug: ABT-712 Extended-release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00935311

M11-063

Details and patient eligibility

About

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.

Full 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).

Enrollment: 122 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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122 participants in 3 patient groups, including a placebo group

ABT-712

Experimental 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).

Treatment:

Drug: ABT-712 Extended-release

Drug: Placebo

Hydrocodone/Acetaminophen

Active Comparator group

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).

Treatment:

Drug: Hydrocodone/Acetaminophen Immediate-release

Drug: Placebo

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo