A Study of Pain Relief in Low Back Pain

Condition(s) targeted: Chronic Low Back Pain

Intervention: Extended release hydrocodone and acetaminophen (Vicodin CR) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Earle Lockhart, M.D., Study Director, Affiliation: Abbott

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Pain Intensity Difference from randomization baseline to each subject's final assessment

Secondary outcome:

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

Minimum age: 21 Years. Maximum age: 75 Years. Gender(s): Both.

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

Tucson, Arizona 85741, United States

Phoenix, Arizona 85029, United States

Tempe, Arizona 85282, United States

Phoenix, Arizona 85023, United States

Fair Oaks, California 95628, United States

Los Gatos, California 95032, United States

Burbank, California 91505, United States

Buena Park, California 90620, United States

Denver, Colorado 80209, United States

Trumbull, Connecticut 06611, United States

Miami, Florida 33156, United States

Oldsmar, Florida 34677, United States

Miami, Florida 33186, United States

Plantation, Florida 33324, United States

DeLand, Florida 32720, United States

West Palm Beach, Florida 33409, United States

Hollywood, Florida 33023, United States

Largo, Florida 33770, United States

Decatur, Georgia 30033, United States

Atlanta, Georgia 30328, United States

Chicago, Illinois 60610, United States

Evansville, Indiana 47714, United States

West Des Moines, Iowa 50265, United States

Prairie Village, Kansas 66206, United States

Shreveport, Louisiana 71105, United States

Metairie, Louisiana 70006, United States

Pasadena, Maryland 21122, United States

Wellesley Hills, Massachusetts 02481, United States

Brockton, Massachusetts 02301, United States

Biloxi, Mississippi 39531, United States

Florissant, Missouri 63031, United States

St. Louis, Missouri 63141, United States

Missoula, Montana 59802, United States

Omaha, Nebraska 68134, United States

Las Vegas, Nevada 89123, United States

Las Vegas, Nevada 89106, United States

New York, New York 10022, United States

Williamsville, New York 14221, United States

Raleigh, North Carolina 27612, United States

Raleigh, North Carolina 27609, United States

Winston-Salem, North Carolina 27103, United States

Cincinnati, Ohio 45227, United States

Cincinnati, Ohio 45242, United States

Cincinnati, Ohio 45245, United States

Oklahoma City, Oklahoma 73103, United States

Downingtown, Pennsylvania 19335, United States

Mechanicsburg, Pennsylvania 17055, United States

Duncansville, Pennsylvania 16635, United States

Cranston, Rhode Island 02920, United States

Greer, South Carolina 29651, United States

Cordova, Tennessee 38018, United States

Killeen, Texas 76543, United States

Austin, Texas 78705, United States

San Antonio, Texas 78233, United States

San Angelo, Texas 76904, United States

San Antonio, Texas 78209, United States

Richardson, Texas 75080, United States

Dallas, Texas 75251, United States

San Antonio, Texas 78218, United States

Bulverde, Texas 78163, United States

Nederland, Texas 77627, United States

Virginia Beach, Virginia 23454, United States

Starting date: May 2006
Last updated: October 24, 2007