A Study of Pain Relief in Low Back Pain - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00325949

Purpose

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

Condition	Intervention	Phase
Chronic Low Back Pain	Drug: Extended release hydrocodone and acetaminophen (Vicodin CR)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Acetaminophen CT 2584 Vicodin Hydrocodone Hydrocodone bitartrate Hycodan

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	450
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325949

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Locations

United States, Arizona

Tucson, Arizona, United States, 85741

Phoenix, Arizona, United States, 85029

Tempe, Arizona, United States, 85282

Phoenix, Arizona, United States, 85023
United States, California

Fair Oaks, California, United States, 95628

Los Gatos, California, United States, 95032

Burbank, California, United States, 91505

Buena Park, California, United States, 90620
United States, Colorado

Denver, Colorado, United States, 80209
United States, Connecticut

Trumbull, Connecticut, United States, 06611
United States, Florida

Miami, Florida, United States, 33156

DeLand, Florida, United States, 32720

Miami, Florida, United States, 33186

Plantation, Florida, United States, 33324

Oldsmar, Florida, United States, 34677

West Palm Beach, Florida, United States, 33409

Hollywood, Florida, United States, 33023

Largo, Florida, United States, 33770
United States, Georgia

Decatur, Georgia, United States, 30033

Atlanta, Georgia, United States, 30328
United States, Illinois

Chicago, Illinois, United States, 60610
United States, Indiana

Evansville, Indiana, United States, 47714
United States, Iowa

West Des Moines, Iowa, United States, 50265
United States, Kansas

Prairie Village, Kansas, United States, 66206
United States, Louisiana

Shreveport, Louisiana, United States, 71105

Metairie, Louisiana, United States, 70006
United States, Maryland

Pasadena, Maryland, United States, 21122
United States, Massachusetts

Wellesley Hills, Massachusetts, United States, 02481

Brockton, Massachusetts, United States, 02301
United States, Mississippi

Biloxi, Mississippi, United States, 39531
United States, Missouri

Florissant, Missouri, United States, 63031

St. Louis, Missouri, United States, 63141
United States, Montana

Missoula, Montana, United States, 59802
United States, Nebraska

Omaha, Nebraska, United States, 68134
United States, Nevada

Las Vegas, Nevada, United States, 89123

Las Vegas, Nevada, United States, 89106
United States, New York

New York, New York, United States, 10022

Williamsville, New York, United States, 14221
United States, North Carolina

Raleigh, North Carolina, United States, 27612

Raleigh, North Carolina, United States, 27609

Winston-Salem, North Carolina, United States, 27103
United States, Ohio

Cincinnati, Ohio, United States, 45227

Cincinnati, Ohio, United States, 45242

Cincinnati, Ohio, United States, 45245
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania

Downingtown, Pennsylvania, United States, 19335

Mechanicsburg, Pennsylvania, United States, 17055

Duncansville, Pennsylvania, United States, 16635
United States, Rhode Island

Cranston, Rhode Island, United States, 02920
United States, South Carolina

Greer, South Carolina, United States, 29651
United States, Tennessee

Cordova, Tennessee, United States, 38018
United States, Texas

San Angelo, Texas, United States, 76904

Austin, Texas, United States, 78705

San Antonio, Texas, United States, 78233

Killeen, Texas, United States, 76543

San Antonio, Texas, United States, 78209

Richardson, Texas, United States, 75080

Dallas, Texas, United States, 75251

San Antonio, Texas, United States, 78218

Bulverde, Texas, United States, 78163

Nederland, Texas, United States, 77627
United States, Virginia

Virginia Beach, Virginia, United States, 23454

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Earle Lockhart, M.D.

Abbott

More Information

No publications provided

Study ID Numbers:	M05-790
Study First Received:	May 11, 2006
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00325949 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory System Agents
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Low Back Pain
Narcotics
Pain
Back Pain
Pharmacologic Actions
Signs and Symptoms
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Hydrocodone
Neurologic Manifestations
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid
Acetaminophen

ClinicalTrials.gov processed this record on November 27, 2009