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) Drug: hydrocodone/acetaminophen extended release (Vicodin CR) Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale)

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

Enrollment:	770
Study Start Date:	May 2006
Study Completion Date:	June 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: arm label (1) hydrocodone/acetaminophen extended release	Drug: Extended release hydrocodone and acetaminophen (Vicodin CR) 2 tablets BID Other Name: hydrocodone / acetaminophen extended release
Experimental: arm label (2) hydrocodone/acetaminophen extended release	Drug: hydrocodone/acetaminophen extended release (Vicodin CR) 1 tablet BID Other Name: hydrocodone/acetaminophen extended release
Placebo Comparator: Arm label (3) placebo	Drug: placebo 2 tablets BID Other Name: placebo

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

Show 63 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Rita Jain, M.D.

Abbott

More Information

No publications provided

Responsible Party:	Earle Lockhart, MD, Abbott Laboratories
ClinicalTrials.gov Identifier:	NCT00325949 History of Changes
Other Study ID Numbers:	M05-790
Study First Received:	May 11, 2006
Last Updated:	July 22, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012