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
Other Name: placebo


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

ClinicalTrials.gov processed this record on April 16, 2014