A Study of Pain Relief in Low Back Pain

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: May 11, 2006
Last updated: July 22, 2011
Last verified: July 2011
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 3

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:

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


Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

  Show 63 Study Locations
Sponsors and Collaborators
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
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Acetaminophen, hydrocodone drug combination
Analgesics, Non-Narcotic
Analgesics, Opioid
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2016