A Study of Pain Relief in Low Back Pain
Chronic Low Back Pain
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
arm label (1) hydrocodone/acetaminophen extended release
arm label (2) hydrocodone/acetaminophen extended release
Arm label (3) placebo