Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain

January 17, 2011 updated by: Abbott

An Open-Label Study Evaluating the Safety and Tolerability of Long Term Administration of Hydrocodone/Acetaminophen Extended ReleaseTablets (Vicodin® CR) in Subjects With Moderate to Severe Chronic, Non-Malignant Pain

The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

431

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
      • Huntsville, Alabama, United States, 35801
        • Site Ref # / Investigator 1696
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Site Reference # / Investigator 1729
      • Mesa, Arizona, United States, 85210
        • Site Reference # / Investigator 1702
      • Peoria, Arizona, United States, 85381
        • Site Reference # / Investigator 1745
      • Tempe, Arizona, United States, 85282
        • Site Ref # / Investigator 1697
      • Tempe, Arizona, United States, 85282
        • Site Ref # / Investigator 1818
      • Tucson, Arizona, United States, 85741
        • Site Reference # / Investigator 1795
    • California
      • Carmichael, California, United States, 95608
        • Site Ref # / Investigator 2555
      • Fair Oaks, California, United States, 95628
        • Site Reference # / Investigator 1688
      • Pasadena, California, United States, 21122
        • Site Reference # / Investigator 1790
      • San Diego, California, United States, 92108
        • Site Reference # / Investigator 1735
      • San Luis Obispo, California, United States, 93401
        • Site Reference # / Investigator 1775
      • Santa Ana, California, United States, 92705
        • Site Ref # / Investigator 1742
      • Tarzana, California, United States, 91356
        • Site Ref # / Investigator 1754
      • Whittier, California, United States, 90601
        • Site Reference # / Investigator 1700
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Site Reference # / Investigator 1690
      • Littleton, Colorado, United States, 80120
        • Site Ref # / Investigator 1713
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Site Ref # / Investigator 1711
    • Florida
      • Clearwater, Florida, United States, 33756
        • Site Reference # / Investigator 1723
      • Clearwater, Florida, United States, 33761
        • Site Ref # / Investigator 1813
      • DeLand, Florida, United States, 32720
        • Site Reference # / Investigator 1718
      • Longwood, Florida, United States, 32779
        • Site Reference # / Investigator 1819
      • Miami, Florida, United States, 33156
        • Site Reference # / Investigator 1809
      • Miami, Florida, United States, 33173
        • Site Reference # / Investigator 1738
      • Orlando, Florida, United States, 32806
        • Site Ref # / Investigator 1716
      • Palm Harbor, Florida, United States, 34684
        • Site Reference # / Investigator 1755
      • Pembroke Pines, Florida, United States, 33024
        • Site Ref # / Investigator 1814
      • Plantation, Florida, United States, 33324
        • Site Reference # / Investigator 1737
      • St. Petersburg, Florida, United States, 33702
        • Site Reference # / Investigator 1747
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Site Reference # / Investigator 1744
      • Chicago, Illinois, United States, 60612
        • Site Reference # / Investigator 1691
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Site Reference # / Investigator 1714
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Site Ref # / Investigator 1739
    • Maryland
      • Owings Mills, Maryland, United States, 21117
        • Site Reference # / Investigator 1810
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Site Ref # / Investigator 1707
      • Wellesley Hills, Massachusetts, United States, 02481-2106
        • Site Reference # / Investigator 1743
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Site Ref # / Investigator 1792
    • Missouri
      • St. Louis, Missouri, United States, 63117
        • Site Reference # / Investigator 1721
      • St. Louis, Missouri, United States, 63141
        • Site Ref # / Investigator 1812
      • St. Louis, Missouri, United States, 63141
        • Site Reference # / Investigator 2424
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Site Ref # / Investigator 1722
      • Omaha, Nebraska, United States, 68134
        • Site Ref # / Investigator 1774
      • Omaha, Nebraska, United States, 68134
        • Site Reference # / Investigator 1789
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Site Reference # / Investigator 1705
      • Las Vegas, Nevada, United States, 89123
        • Site Reference # / Investigator 1791
    • New Jersey
      • Medford, New Jersey, United States, 08055
        • Site Reference # / Investigator 1701
      • Trenton, New Jersey, United States, 08629-1986
        • Site Reference # / Investigator 2461
    • New York
      • Binghamton, New York, United States, 13901
        • Site Reference # / Investigator 1726
      • New York, New York, United States, 10022
        • Site Reference # / Investigator 1815
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Site Reference # / Investigator 1708
      • Monroe, North Carolina, United States, 28112
        • Site Ref # / Investigator 1730
      • Raleigh, North Carolina, United States, 27609
        • Site Reference # / Investigator 1741
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Site Reference # / Investigator 1689
      • Cincinnati, Ohio, United States, 45236
        • Site Ref # / Investigator 1694
      • Cleveland, Ohio, United States, 44122
        • Site Ref # / Investigator 1816
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Site Reference # / Investigator 1715
    • Oregon
      • Portland, Oregon, United States, 97239
        • Site Reference # / Investigator 2423
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Site Reference # / Investigator 1794
      • Duncansville, Pennsylvania, United States, 16635
        • Site Reference # / Investigator 1749
      • Erie, Pennsylvania, United States, 16508-1256
        • Site Reference # / Investigator 1752
      • Mechanicsburg, Pennsylvania, United States, 17055
        • Site Reference # / Investigator 1709
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Site Reference # / Investigator 1757
      • Selmer, Tennessee, United States, 38375
        • Site Reference # / Investigator 1727
    • Texas
      • Austin, Texas, United States, 78705
        • Site Ref # / Investigator 1692
      • Austin, Texas, United States, 78728
        • Site Reference # / Investigator 1722
      • Dallas, Texas, United States, 75235
        • Site Reference # / Investigator 2425
      • Fort Worth, Texas, United States, 76135
        • Site Reference # / Investigator 1699
      • Killeen, Texas, United States, 76543
        • Site Ref # / Investigator 1725
      • San Angelo, Texas, United States, 76904
        • Site Reference # / Investigator 1710
      • San Antonio, Texas, United States, 78209
        • Site Reference # / Investigator 1686
      • San Antonio, Texas, United States, 78217
        • Site Reference # / Investigator 2426
      • San Antonio, Texas, United States, 78229
        • Site Reference # / Investigator 1808
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Site Reference # / Investigator 1732
      • Salt Lake City, Utah, United States, 84109
        • Site Reference # / Investigator 1740
    • Virginia
      • Norfolk, Virginia, United States, 23502-9921
        • Site Ref # / Investigator 1733
      • Virginia Beach, Virginia, United States, 23455
        • Site Reference # / Investigator 1719

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 between 21 and 75 years of age

    • Females must be of non-child bearing potential or practicing birth control
  • Moderate to severe mechanical low back pain OR moderate to severe OA of the hip or knee pain
  • Require medicine for pain the majority of days in the previous 3 months, AND for at least 4 days per week, during the previous 4 weeks.
  • Pain is not controlled with non-opioid analgesics or is contraindicated due to side effects and/or currently receiving opioid therapy equivalent to 40 mg/day of morphine or less

Exclusion Criteria:

  • Pregnant and/or breastfeeding females or females planning to become pregnant during the course of the study
  • Incapacitated, bedridden, or confined to a wheelchair permitting little or no self-care
  • Injury to the index joint or lower back within 3 months of study

  • History of any of the following:

    • Major surgery to the lower back within the last 5 years OR
    • Joint replacement/reconstruction to the index joint OR
    • Arthroscopic or open surgery to the index joint within the last year OR
    • Any surgery within 3 months of study
  • Osteoporotic compression fracture, traumatic vertebral fracture or invasive intervention for low back pain within the last year.
  • Abnormal neurological exam, or lower extremity symptoms characteristic of neurogenic pain
  • History of inflammatory or infectious arthritis, tumors or infections of spinal cord, spinal stenosis, fibromyalgia or other chronic painful condition
  • Severe gastrointestinal narrowing
  • History of peritonitis, cystic fibrosis, chronic intestinal eudoobstruction, or Meckel's diverticulum.

  • Has received

    • Oral, intramuscular (IM), intravenous (IV) or non-index joint intra- articular corticosteroids within 1 month of study OR
    • Intra-articular corticosteroids at the index joint or epidural corticosteroids to the lower back region within 2 months of study, OR
    • Viscosupplementation therapy to index joint within 4 months of study
  • History of drug (licit or illicit) or alcohol abuse/addiction
  • Positive result for drugs of abuse at screening.
  • Chronic heavy drinker, consuming more than 4 alcoholic drinks per day.
  • History of malnutrition or starvation or is likely to fast for more than 4 consecutive days during the course of the study.
  • Medical condition or illness other than OA/CLBP, which is not well controlled
  • History of allergic reaction or a clinically significant sensitivity or intolerance to opioids and/or acetaminophen.
  • Newly diagnosed medical condition
  • Clinically significant infection/injury/illness within 1 month of study
  • Receiving systemic chemotherapy, or has an active malignancy of any type, or has been diagnosed with cancer within the past 5 years. Basal cell carcinoma of the skin that has been successfully treated will be permitted.
  • Known or suspected history of Human Immunodeficiency Virus.
  • Positive Hepatitis Screen
  • Clinically significant abnormalities in clinical chemistry, hematology or urinalysis
  • Received any investigational drug within 1 month of study
  • History of major psychiatric disorder
  • Active or uncontrolled seizure disorder.
  • Requires treatment with monoamine oxidase inhibitors (MAOIs), or tricyclic antidepressants during the course of the study.
  • Surgical procedure planned, or scheduled during the course of this study.
  • Ongoing workman's compensation claim or litigation.
  • Previous participation in the M03-666 study.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hydrocodone/acetaminophen extended release
Drug: Hydrocodone/Acetaminophen on Extended Release
2 tablets twice daily
Other Names:
  • ABT-712

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation
Time Frame: 56 weeks
Long term safety
56 weeks

Collaborators and Investigators

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

Sponsor

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

June 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 17, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M03-666

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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