NCT00935311

Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

A Randomized, Multicenter, Single-blind, Placebo-controlled Study Comparing the Analgesic Efficacy and Safety of Hydrocodone/ Acetaminophen Extended-release Tablets and Hydrocodone/Acetaminophen (NORCO) to Placebo in Subjects With Acute Pain Following Third Molar Tooth Extraction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	ABT-712 Extended-release	ABT-712 extended-release tablet
DRUG	Hydrocodone/Acetaminophen Immediate-release	Hydrocodone/acetaminophen immediate-release tablet
DRUG	Placebo	Placebo tablet

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-07-09
• Last updated: 2014-04-08
• Results posted: 2014-03-07

Locations

3 sites across 1 country: United States