A Study of Pain Relief in Low Back Pain
- Conditions
- Chronic Low Back Pain
- Interventions
- Drug: hydrocodone/acetaminophen extended release (Vicodin CR)Drug: placebo
- Registration Number
- NCT00325949
- Lead Sponsor
- Abbott
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 770
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description arm label (1) hydrocodone/acetaminophen extended release Extended release hydrocodone and acetaminophen (Vicodin CR) - arm label (2) hydrocodone/acetaminophen extended release hydrocodone/acetaminophen extended release (Vicodin CR) - Arm label (3) placebo placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (63)
Site Ref # / Investigator 2216
🇺🇸Hueytown, Alabama, United States
Site Ref # / Investigator 2605
🇺🇸Phoenix, Arizona, United States
Site Ref # / Investigator 1990
🇺🇸Phoenix, Arizona, United States
Site Ref # / Investigator 1974
🇺🇸Tempe, Arizona, United States
Site Ref # / Investigator 1977
🇺🇸Tucson, Arizona, United States
Site Ref # / Investigator 1992
🇺🇸Buena Park, California, United States
Site Ref # / Investigator 1993
🇺🇸Burbank, California, United States
Site Ref # / Investigator 2219
🇺🇸Fair Oaks, California, United States
Site Ref # / Investigator 1989
🇺🇸Los Gatos, California, United States
Site Ref # / Investigator 2157
🇺🇸Denver, Colorado, United States
Scroll for more (53 remaining)Site Ref # / Investigator 2216🇺🇸Hueytown, Alabama, United States