NCT01038609

Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

A Randomized, Multicenter, Single-Blind Study Comparing Hydrocodone/Acetaminophen Extended Release 10/650, Morphine Extended Release, and Acetaminophen to Placebo in Subjects With Acute Pain Following Bunionectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.

Detailed description

The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol. After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 5 treatment arms. In order to maintain the single-blind nature of the study, all participants were dosed with study drug (active and/or placebo) every 6 hours.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Hydrocodone/Acetaminophen Extended Release
DRUG	Acetaminophen
DRUG	Morphine Extended Release
DRUG	Placebo

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-12-24
• Last updated: 2014-04-08
• Results posted: 2014-03-07

Locations

4 sites across 1 country: United States