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

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