Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Males and Females between 21 and 75 years of age
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:
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
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 purpose
Allocation
Interventional model
Masking
431 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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