Clinical trial NCT00195728: Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Chronic, Non-malignant Pain
Keywords: Hydrocodone/Acetaminophen
Vicodin CR
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 431
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety evaluation
timeFrame: 56 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Site Ref # / Investigator 1696
state: Alabama
city: Chandler
country: United States
facility: Site Reference # / Investigator 1729
state: Arizona
city: Mesa
country: United States
facility: Site Reference # / Investigator 1702
state: Arizona
city: Peoria
country: United States
facility: Site Reference # / Investigator 1745
state: Arizona
city: Tempe
country: United States
facility: Site Ref # / Investigator 1697
state: Arizona
city: Tempe
country: United States
facility: Site Ref # / Investigator 1818
state: Arizona
city: Tucson
country: United States
facility: Site Reference # / Investigator 1795
state: Arizona
city: Carmichael
country: United States
facility: Site Ref # / Investigator 2555
state: California
city: Fair Oaks
country: United States
facility: Site Reference # / Investigator 1688
state: California
city: Pasadena
country: United States
facility: Site Reference # / Investigator 1790
state: California
city: San Diego
country: United States
facility: Site Reference # / Investigator 1735
state: California
city: San Luis Obispo
country: United States
facility: Site Reference # / Investigator 1775
state: California
city: Santa Ana
country: United States
facility: Site Ref # / Investigator 1742
state: California
city: Tarzana
country: United States
facility: Site Ref # / Investigator 1754
state: California
city: Whittier
country: United States
facility: Site Reference # / Investigator 1700
state: California
city: Colorado Springs
country: United States
facility: Site Reference # / Investigator 1690
state: Colorado
city: Littleton
country: United States
facility: Site Ref # / Investigator 1713
state: Colorado
city: Bristol
country: United States
facility: Site Ref # / Investigator 1711
state: Connecticut
city: Clearwater
country: United States
facility: Site Reference # / Investigator 1723
state: Florida
city: Clearwater
country: United States
facility: Site Ref # / Investigator 1813
state: Florida
city: DeLand
country: United States
facility: Site Reference # / Investigator 1718
state: Florida
city: Longwood
country: United States
facility: Site Reference # / Investigator 1819
state: Florida
city: Miami
country: United States
facility: Site Reference # / Investigator 1809
state: Florida
city: Miami
country: United States
facility: Site Reference # / Investigator 1738
state: Florida
city: Orlando
country: United States
facility: Site Ref # / Investigator 1716
state: Florida
city: Palm Harbor
country: United States
facility: Site Reference # / Investigator 1755
state: Florida
city: Pembroke Pines
country: United States
facility: Site Ref # / Investigator 1814
state: Florida
city: Plantation
country: United States
facility: Site Reference # / Investigator 1737
state: Florida
city: St. Petersburg
country: United States
facility: Site Reference # / Investigator 1747
state: Florida
city: Arlington Heights
country: United States
facility: Site Reference # / Investigator 1744
state: Illinois
city: Chicago
country: United States
facility: Site Reference # / Investigator 1691
state: Illinois
city: Evansville
country: United States
facility: Site Reference # / Investigator 1714
state: Indiana
city: Metairie
country: United States
facility: Site Ref # / Investigator 1739
state: Louisiana
city: Owings Mills
country: United States
facility: Site Reference # / Investigator 1810
state: Maryland
city: Fall River
country: United States
facility: Site Ref # / Investigator 1707
state: Massachusetts
city: Wellesley Hills
country: United States
facility: Site Reference # / Investigator 1743
state: Massachusetts
city: Jackson
country: United States
facility: Site Ref # / Investigator 1792
state: Mississippi
city: St. Louis
country: United States
facility: Site Reference # / Investigator 1721
state: Missouri
city: St. Louis
country: United States
facility: Site Ref # / Investigator 1812
state: Missouri
city: St. Louis
country: United States
facility: Site Reference # / Investigator 2424
state: Missouri
city: Omaha
country: United States
facility: Site Ref # / Investigator 1722
state: Nebraska
city: Omaha
country: United States
facility: Site Ref # / Investigator 1774
state: Nebraska
city: Omaha
country: United States
facility: Site Reference # / Investigator 1789
state: Nebraska
city: Las Vegas
country: United States
facility: Site Reference # / Investigator 1705
state: Nevada
city: Las Vegas
country: United States
facility: Site Reference # / Investigator 1791
state: Nevada
city: Medford
country: United States
facility: Site Reference # / Investigator 1701
state: New Jersey
city: Trenton
country: United States
facility: Site Reference # / Investigator 2461
state: New Jersey
city: Binghamton
country: United States
facility: Site Reference # / Investigator 1726
state: New York
city: New York
country: United States
facility: Site Reference # / Investigator 1815
state: New York
city: Charlotte
country: United States
facility: Site Reference # / Investigator 1708
state: North Carolina
city: Monroe
country: United States
facility: Site Ref # / Investigator 1730
state: North Carolina
city: Raleigh
country: United States
facility: Site Reference # / Investigator 1741
state: North Carolina
city: Cincinnati
country: United States
facility: Site Reference # / Investigator 1689
state: Ohio
city: Cincinnati
country: United States
facility: Site Ref # / Investigator 1694
state: Ohio
city: Cleveland
country: United States
facility: Site Ref # / Investigator 1816
state: Ohio
city: Oklahoma City
country: United States
facility: Site Reference # / Investigator 1715
state: Oklahoma
city: Portland
country: United States
facility: Site Reference # / Investigator 2423
state: Oregon
city: Beaver
country: United States
facility: Site Reference # / Investigator 1794
state: Pennsylvania
city: Duncansville
country: United States
facility: Site Reference # / Investigator 1749
state: Pennsylvania
city: Erie
country: United States
facility: Site Reference # / Investigator 1752
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Site Reference # / Investigator 1709
state: Pennsylvania
city: Cordova
country: United States
facility: Site Reference # / Investigator 1757
state: Tennessee
city: Selmer
country: United States
facility: Site Reference # / Investigator 1727
state: Tennessee
city: Austin
country: United States
facility: Site Ref # / Investigator 1692
state: Texas
city: Austin
country: United States
facility: Site Reference # / Investigator 1722
state: Texas
city: Dallas
country: United States
facility: Site Reference # / Investigator 2425
state: Texas
city: Fort Worth
country: United States
facility: Site Reference # / Investigator 1699
state: Texas
city: Killeen
country: United States
facility: Site Ref # / Investigator 1725
state: Texas
city: San Angelo
country: United States
facility: Site Reference # / Investigator 1710
state: Texas
city: San Antonio
country: United States
facility: Site Reference # / Investigator 1686
state: Texas
city: San Antonio
country: United States
facility: Site Reference # / Investigator 2426
state: Texas
city: San Antonio
country: United States
facility: Site Reference # / Investigator 1808
state: Texas
city: Salt Lake City
country: United States
facility: Site Reference # / Investigator 1732
state: Utah
city: Salt Lake City
country: United States
facility: Site Reference # / Investigator 1740
state: Utah
city: Norfolk
country: United States
facility: Site Ref # / Investigator 1733
state: Virginia
city: Virginia Beach
country: United States
facility: Site Reference # / Investigator 1719
state: Virginia
Study officials:
affiliation: Abbott
name: Rita Jain, MD
role: STUDY_DIRECTOR
References: