A Study of Pain Relief in Low Back Pain

July 22, 2011 updated by: Abbott

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

770

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hueytown, Alabama, United States, 35023
        • Site Ref # / Investigator 2216
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Site Ref # / Investigator 2605
      • Phoenix, Arizona, United States, 85029
        • Site Ref # / Investigator 1990
      • Tempe, Arizona, United States, 85282
        • Site Ref # / Investigator 1974
      • Tucson, Arizona, United States, 85741
        • Site Ref # / Investigator 1977
    • California
      • Buena Park, California, United States, 90620
        • Site Ref # / Investigator 1992
      • Burbank, California, United States, 91505
        • Site Ref # / Investigator 1993
      • Fair Oaks, California, United States, 95628
        • Site Ref # / Investigator 2219
      • Los Gatos, California, United States, 95032
        • Site Ref # / Investigator 1989
    • Colorado
      • Denver, Colorado, United States, 80209
        • Site Ref # / Investigator 2157
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • Site Ref # / Investigator 1994
    • Florida
      • Clearwater, Florida, United States, 33756
        • Site Ref # / Investigator 2208
      • DeLand, Florida, United States, 32720
        • Site Ref # / Investigator 2210
      • Hollywood, Florida, United States, 33023
        • Site Ref # / Investigator 2207
      • Miami, Florida, United States, 33156
        • Site Ref # / Investigator 2204
      • Miami, Florida, United States, 33186
        • Site Ref # / Investigator 2205
      • Oldsmar, Florida, United States, 34677
        • Site Ref # / Investigator 2214
      • Plantation, Florida, United States, 33324
        • Site Ref # / Investigator 2135
      • West Palm Beach, Florida, United States, 33409-3509
        • Site Ref # / Investigator 2134
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Site Ref # / Investigator 1975
      • Decatur, Georgia, United States, 30033
        • Site Ref # / Investigator 1991
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Site Ref # / Investigator 1985
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Site Ref # / Investigator 1978
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Site Ref # / Investigator 1988
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Site Ref # / Investigator 2580
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Site Ref # / Investigator 2209
      • Shreveport, Louisiana, United States, 71103
        • Site Ref # / Investigator 1976
    • Maryland
      • Pasadena, Maryland, United States, 21122
        • Site Ref # / Investigator 2203
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Site Ref # / Investigator 2603
      • Wellesley Hills, Massachusetts, United States, 02481-2106
        • Site Ref # / Investigator 2156
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • Site Ref # / Investigator 3420
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Site Ref # / Investigator 2556
      • St. Louis, Missouri, United States, 63141
        • Site Ref # / Investigator 1980
    • Montana
      • Missoula, Montana, United States, 59802
        • Site Ref # / Investigator 1982
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Site Ref # / Investigator 1986
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Site Ref # / Investigator 3421
      • Las Vegas, Nevada, United States, 89123
        • Site Ref # / Investigator 2206
    • New York
      • New York, New York, United States, 10022
        • Site Ref # / Investigator 1973
      • Williamsville, New York, United States, 14221
        • Site Ref # / Investigator 2578
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Site Ref # / Investigator 1983
      • Raleigh, North Carolina, United States, 27612
        • Site Ref # / Investigator 2606
      • Winston-Salem, North Carolina, United States, 27103
        • Site Ref # / Investigator 5161
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Site Ref # / Investigator 2218
      • Cincinnati, Ohio, United States, 45242
        • Site Ref # / Investigator 1995
      • Cincinnati, Ohio, United States, 45245
        • Site Ref # / Investigator 1987
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Site Ref # / Investigator 2211
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
        • Site Ref # / Investigator 2215
      • Duncansville, Pennsylvania, United States, 16635
        • Site Ref # / Investigator 2579
      • Mechanicsburg, Pennsylvania, United States, 17055
        • Site Ref # / Investigator 2213
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Site Ref # / Investigator 2137
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Site Ref # / Investigator 2221
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Site Ref # / Investigator 1984
    • Texas
      • Austin, Texas, United States, 78705
        • Site Ref # / Investigator 2217
      • Bulverde, Texas, United States, 78163
        • Site Ref # / Investigator 2607
      • Dallas, Texas, United States, 75251
        • Site Ref # / Investigator 2590
      • Killeen, Texas, United States, 76543
        • Site Ref # / Investigator 2117
      • Nederland, Texas, United States, 77627
        • Site Ref # / Investigator 2604
      • Richardson, Texas, United States, 75080
        • Site Ref # / Investigator 1979
      • San Angelo, Texas, United States, 76904
        • Site Ref # / Investigator 2212
      • San Antonio, Texas, United States, 78127
        • Site Ref # / Investigator 1981
      • San Antonio, Texas, United States, 78209
        • Site Ref # / Investigator 2220
      • San Antonio, Texas, United States, 78218
        • Site Ref # / Investigator 2608
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Site Ref # / Investigator 2158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arm label (1) hydrocodone/acetaminophen extended release
Drug: Extended release hydrocodone and acetaminophen (Vicodin CR)
2 tablets BID
Other Names:
  • hydrocodone / acetaminophen extended release
Experimental: arm label (2) hydrocodone/acetaminophen extended release
Drug: hydrocodone/acetaminophen extended release (Vicodin CR)
1 tablet BID
Other Names:
  • hydrocodone/acetaminophen extended release
Placebo Comparator: Arm label (3) placebo
Drug: placebo
2 tablets BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 Weeks

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Rita Jain, M.D., Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

May 11, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 15, 2006

Study Record Updates

Last Update Posted (Estimate)

July 25, 2011

Last Update Submitted That Met QC Criteria

July 22, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M05-790

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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