Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain
- Conditions
- Moderate to Severe Chronic, Non-malignant Pain
- Interventions
- Drug: Hydrocodone/Acetaminophen on Extended Release
- Registration Number
- NCT00195728
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 431
-
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
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description hydrocodone/acetaminophen extended release Hydrocodone/Acetaminophen on Extended Release -
- Primary Outcome Measures
Name Time Method Safety evaluation 56 weeks Long term safety
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (76)
Site Ref # / Investigator 1813
🇺🇸Clearwater, Florida, United States
Site Reference # / Investigator 1741
🇺🇸Raleigh, North Carolina, United States
Site Reference # / Investigator 1719
🇺🇸Virginia Beach, Virginia, United States
Site Ref # / Investigator 2555
🇺🇸Carmichael, California, United States
Site Ref # / Investigator 1814
🇺🇸Pembroke Pines, Florida, United States
Site Ref # / Investigator 1754
🇺🇸Tarzana, California, United States
Site Reference # / Investigator 1729
🇺🇸Chandler, Arizona, United States
Site Reference # / Investigator 1795
🇺🇸Tucson, Arizona, United States
Site Ref # / Investigator 1818
🇺🇸Tempe, Arizona, United States
Site Ref # / Investigator 1792
🇺🇸Jackson, Mississippi, United States
Site Ref # / Investigator 1739
🇺🇸Metairie, Louisiana, United States
Site Reference # / Investigator 1810
🇺🇸Owings Mills, Maryland, United States
Site Reference # / Investigator 1690
🇺🇸Colorado Springs, Colorado, United States
Site Reference # / Investigator 1700
🇺🇸Whittier, California, United States
Site Ref # / Investigator 1716
🇺🇸Orlando, Florida, United States
Site Reference # / Investigator 1738
🇺🇸Miami, Florida, United States
Site Reference # / Investigator 1809
🇺🇸Miami, Florida, United States
Site Ref # / Investigator 1816
🇺🇸Cleveland, Ohio, United States
Site Reference # / Investigator 2423
🇺🇸Portland, Oregon, United States
Site Reference # / Investigator 1735
🇺🇸San Diego, California, United States
Site Reference # / Investigator 1732
🇺🇸Salt Lake City, Utah, United States
Site Ref # / Investigator 1722
🇺🇸Omaha, Nebraska, United States
Site Reference # / Investigator 1789
🇺🇸Omaha, Nebraska, United States
Site Reference # / Investigator 1705
🇺🇸Las Vegas, Nevada, United States
Site Reference # / Investigator 1791
🇺🇸Las Vegas, Nevada, United States
Site Ref # / Investigator 1694
🇺🇸Cincinnati, Ohio, United States
Site Reference # / Investigator 1689
🇺🇸Cincinnati, Ohio, United States
Site Reference # / Investigator 2426
🇺🇸San Antonio, Texas, United States
Site Reference # / Investigator 1715
🇺🇸Oklahoma City, Oklahoma, United States
Site Reference # / Investigator 1686
🇺🇸San Antonio, Texas, United States
Site Reference # / Investigator 1808
🇺🇸San Antonio, Texas, United States
Site Reference # / Investigator 1790
🇺🇸Pasadena, California, United States
Site Reference # / Investigator 1737
🇺🇸Plantation, Florida, United States
Site Reference # / Investigator 1744
🇺🇸Arlington Heights, Illinois, United States
Site Reference # / Investigator 1688
🇺🇸Fair Oaks, California, United States
Site Reference # / Investigator 1723
🇺🇸Clearwater, Florida, United States
Site Ref # / Investigator 1707
🇺🇸Fall River, Massachusetts, United States
Site Ref # / Investigator 1742
🇺🇸Santa Ana, California, United States
Site Reference # / Investigator 1718
🇺🇸DeLand, Florida, United States
Site Reference # / Investigator 1721
🇺🇸St. Louis, Missouri, United States
Site Reference # / Investigator 1755
🇺🇸Palm Harbor, Florida, United States
Site Reference # / Investigator 1757
🇺🇸Cordova, Tennessee, United States
Site Reference # / Investigator 1747
🇺🇸St. Petersburg, Florida, United States
Site Reference # / Investigator 1691
🇺🇸Chicago, Illinois, United States
Site Reference # / Investigator 1714
🇺🇸Evansville, Indiana, United States
Site Reference # / Investigator 1745
🇺🇸Peoria, Arizona, United States
Site Reference # / Investigator 1702
🇺🇸Mesa, Arizona, United States
Site Ref # / Investigator 1696
🇺🇸Huntsville, Alabama, United States
Site Ref # / Investigator 1697
🇺🇸Tempe, Arizona, United States
Site Reference # / Investigator 1819
🇺🇸Longwood, Florida, United States
Site Reference # / Investigator 1775
🇺🇸San Luis Obispo, California, United States
Site Ref # / Investigator 1713
🇺🇸Littleton, Colorado, United States
Site Ref # / Investigator 1711
🇺🇸Bristol, Connecticut, United States
Site Ref # / Investigator 1812
🇺🇸St. Louis, Missouri, United States
Site Reference # / Investigator 2424
🇺🇸St. Louis, Missouri, United States
Site Reference # / Investigator 1743
🇺🇸Wellesley Hills, Massachusetts, United States
Site Ref # / Investigator 1774
🇺🇸Omaha, Nebraska, United States
Site Reference # / Investigator 1701
🇺🇸Medford, New Jersey, United States
Site Reference # / Investigator 1815
🇺🇸New York, New York, United States
Site Reference # / Investigator 2461
🇺🇸Trenton, New Jersey, United States
Site Reference # / Investigator 1726
🇺🇸Binghamton, New York, United States
Site Reference # / Investigator 1708
🇺🇸Charlotte, North Carolina, United States
Site Ref # / Investigator 1730
🇺🇸Monroe, North Carolina, United States
Site Reference # / Investigator 1749
🇺🇸Duncansville, Pennsylvania, United States
Site Reference # / Investigator 1794
🇺🇸Beaver, Pennsylvania, United States
Site Reference # / Investigator 1752
🇺🇸Erie, Pennsylvania, United States
Site Reference # / Investigator 1727
🇺🇸Selmer, Tennessee, United States
Site Reference # / Investigator 1709
🇺🇸Mechanicsburg, Pennsylvania, United States
Site Ref # / Investigator 1725
🇺🇸Killeen, Texas, United States
Site Reference # / Investigator 1722
🇺🇸Austin, Texas, United States
Site Reference # / Investigator 1710
🇺🇸San Angelo, Texas, United States
Site Ref # / Investigator 1692
🇺🇸Austin, Texas, United States
Site Reference # / Investigator 2425
🇺🇸Dallas, Texas, United States
Site Reference # / Investigator 1699
🇺🇸Fort Worth, Texas, United States
Site Ref # / Investigator 1733
🇺🇸Norfolk, Virginia, United States
Site Reference # / Investigator 1740
🇺🇸Salt Lake City, Utah, United States