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

Completed · Phase 3

Conditions studied: Moderate to Severe Chronic, Non-malignant Pain

In brief

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.

Key facts

Study ID

NCT00195728

Run by

Abbott

People needed

431

Starts

2005-06-01

Expected to finish

2006-12-01

Last updated by the study team

2011-01-19

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site Reference # / Investigator 1729 — Chandler, Arizona, United States
• Site Reference # / Investigator 1702 — Mesa, Arizona, United States
• Site Reference # / Investigator 1745 — Peoria, Arizona, United States
• Site Ref # / Investigator 1697 — Tempe, Arizona, United States
• Site Ref # / Investigator 1818 — Tempe, Arizona, United States
• Site Reference # / Investigator 1795 — Tucson, Arizona, United States
• Site Ref # / Investigator 2555 — Carmichael, California, United States
• Site Reference # / Investigator 1688 — Fair Oaks, California, United States
• Site Reference # / Investigator 1790 — Pasadena, California, United States
• Site Reference # / Investigator 1735 — San Diego, California, United States
• Site Reference # / Investigator 1775 — San Luis Obispo, California, United States
• Site Ref # / Investigator 1742 — Santa Ana, California, United States
• Site Ref # / Investigator 1754 — Tarzana, California, United States
• Site Reference # / Investigator 1700 — Whittier, California, United States
• Site Reference # / Investigator 1690 — Colorado Springs, Colorado, United States
• Site Ref # / Investigator 1713 — Littleton, Colorado, United States
• Site Ref # / Investigator 1711 — Bristol, Connecticut, United States
• Site Reference # / Investigator 1723 — Clearwater, Florida, United States
• Site Ref # / Investigator 1813 — Clearwater, Florida, United States
• Site Reference # / Investigator 1718 — DeLand, Florida, United States
• Site Reference # / Investigator 1819 — Longwood, Florida, United States
• Site Reference # / Investigator 1809 — Miami, Florida, United States
• Site Reference # / Investigator 1738 — Miami, Florida, United States
• Site Ref # / Investigator 1716 — Orlando, Florida, United States
• Site Ref # / Investigator 1696 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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