Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant 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: NCT00195728
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 19, 2011
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Chronic, Non-malignant Pain Drug: Hydrocodone/Acetaminophen on Extended Release Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: hydrocodone/acetaminophen extended release Drug: Hydrocodone/Acetaminophen on Extended Release
2 tablets twice daily
Other Name: ABT-712

Primary Outcome Measures :
  1. Safety evaluation [ Time Frame: 56 weeks ]
    Long term safety

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00195728

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

Responsible Party: Andrea Best, DO, MPH, Abbott Identifier: NCT00195728     History of Changes
Other Study ID Numbers: M03-666
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011

Keywords provided by Abbott:
Vicodin CR

Additional relevant MeSH terms:
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