A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

Abbott

Status and phase

Completed

Phase 2

Conditions

Pain

Treatments

Drug: Hydrocodone/Acetaminophen Extended Release

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00404391

M03-609

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

Enrollment

210 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female ages 18 to 65
Females must be of non-childbearing potential or practicing birth control
Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery

Exclusion criteria

Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs
Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study
Is associated with any currently ongoing research study