COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

A Study of Pain Relief in Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00325949
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : July 25, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: Extended release hydrocodone and acetaminophen (Vicodin CR) Drug: hydrocodone/acetaminophen extended release (Vicodin CR) Drug: placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pain Intensity Difference from randomization baseline to each subject's final assessment [ Time Frame: 12 Weeks ]
    Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale)

Secondary Outcome Measures :
  1. Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period
  2. Pain Intensity Difference from randomization baseline to each scheduled assessment
  3. Global Assessments of Study Drug and Back Pain Status
  4. Roland-Morris Disability Questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00325949

Show Show 63 study locations
Sponsors and Collaborators
Layout table for investigator information
Study Director: Rita Jain, M.D. Abbott
Layout table for additonal information
Responsible Party: Earle Lockhart, MD, Abbott Laboratories Identifier: NCT00325949    
Other Study ID Numbers: M05-790
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Neurologic Manifestations
Acetaminophen, hydrocodone drug combination
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents