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

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.

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.