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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Hydrocodone/Acetaminophen Extended Release
* Drug: Hydrocodone/Acetaminophen Extended Release
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: hydrocodone/acetaminophen extended release<br> | Drug: Hydrocodone/Acetaminophen Extended Release<br>* 1 tablet every 12 hours<br>* Other names: ABT-712;|
| Experimental: Arm 2: hydrocodone/acetaminophen extended release<br> | Drug: Hydrocodone/Acetaminophen Extended Release<br>* 2 tablets every 12 hours<br>* Other names: ABT-712;|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* 2 tablets every 12 hours<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration | Pain relief measured by a 100mm Visual Analog Scale (VAS) | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time interval weighted sum of pain intensity difference (SPID)scores | Sum of pain intensity difference | 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moderate to severe pain following bunionectomy surgery