A Study of Pain Relief in Low Back Pain

Abbott

Status and phase

Completed

Phase 3

Conditions

Chronic Low Back Pain

Treatments

Drug: Extended release hydrocodone and acetaminophen (Vicodin CR)

Drug: hydrocodone/acetaminophen extended release (Vicodin CR)

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00325949

M05-790

Details and patient eligibility

About

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

Enrollment

770 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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