A Study of Pain Relief in Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain

Official Title
-----------------
A Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Drug: Extended release hydrocodone and acetaminophen (Vicodin CR)
* Drug: hydrocodone/acetaminophen extended release (Vicodin CR)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, ages 21-75 years If female, must be of non-child bearing potential or practicing birth control Has a history of chronic low back pain for at least 6 months Requires medication for the management of the chronic low back pain Has sufficient pain to justify the use of around-the-clock opioids Exclusion Criteria: Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study Is allergic or has had a serious reaction to hydrocodone, other opioids, or acetaminophen Cannot discontinue pain medications, even for the short time prior to the study start Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery, or plans to have surgery Has a history of gastric bypass surgery or preexisting gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract Has a history of malnutrition or starvation Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder Is a pregnant or breastfeeding woman Is incapacitated, bedridden, or confined to a wheelchair Has initiated any new therapy or medication for chronic low back pain within 1 month of screening Has had surgery, certain types of low back procedures, injured, or received certain medications for chronic low back pain within a certain specified time frame Has back pain due to or associated with certain types of conditions Has other conditions that may cause pain, such as rheumatoid arthritis, gout, or fibromyalgia

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 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 label (1) hydrocodone/acetaminophen extended release<br> | Drug: Extended release hydrocodone and acetaminophen (Vicodin CR)<br>* 2 tablets BID<br>* Other names: hydrocodone / acetaminophen extended release;|
| Experimental: arm label (2) hydrocodone/acetaminophen extended release<br> | Drug: hydrocodone/acetaminophen extended release (Vicodin CR)<br>* 1 tablet BID<br>* Other names: hydrocodone/acetaminophen extended release;|
| Placebo Comparator: Arm label (3) placebo<br> | Drug: placebo<br>* 2 tablets BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Difference from randomization baseline to each subject's final assessment | Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale) | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period |  |  | 
| Pain Intensity Difference from randomization baseline to each scheduled assessment |  |  | 
| Global Assessments of Study Drug and Back Pain Status |  |  | 
| Roland-Morris Disability Questionnaire |  |  |