Chronic Low Back Pain
Conditions
Brief summary
This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain
Interventions
DRUGExtended release hydrocodone and acetaminophen (Vicodin CR)
2 tablets BID
DRUGhydrocodone/acetaminophen extended release (Vicodin CR)
1 tablet BID
DRUGplacebo
2 tablets BID
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females, ages 21-75 years * If female, must be of non-child bearing potential or practicing birth control * Has a history of chronic low back pain for at least 6 months * Requires medication for the management of the chronic low back pain * Has sufficient pain to justify the use of around-the-clock opioids
Exclusion criteria
* Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study * Is allergic or has had a serious reaction to hydrocodone, other opioids, or acetaminophen * Cannot discontinue pain medications, even for the short time prior to the study start * Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery, or plans to have surgery * Has a history of gastric bypass surgery or preexisting gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract * Has a history of malnutrition or starvation * Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day * Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder * Is a pregnant or breastfeeding woman * Is incapacitated, bedridden, or confined to a wheelchair * Has initiated any new therapy or medication for chronic low back pain within 1 month of screening * Has had surgery, certain types of low back procedures, injured, or received certain medications for chronic low back pain within a certain specified time frame * Has back pain due to or associated with certain types of conditions * Has other conditions that may cause pain, such as rheumatoid arthritis, gout, or fibromyalgia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Difference from randomization baseline to each subject's final assessment | 12 Weeks | Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale) |
Secondary
| Measure | Time frame |
|---|---|
| Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period | — |
| Pain Intensity Difference from randomization baseline to each scheduled assessment | — |
| Global Assessments of Study Drug and Back Pain Status | — |
| Roland-Morris Disability Questionnaire | — |
Countries
United States
Outcome results
None listed