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 1982
🇺🇸Missoula, Montana, United States
Site Ref # / Investigator 2204
🇺🇸Miami, Florida, United States
Site Ref # / Investigator 2205
🇺🇸Miami, Florida, United States
Site Ref # / Investigator 1988
🇺🇸West Des Moines, Iowa, United States
Site Ref # / Investigator 2607
🇺🇸Bulverde, Texas, United States
Site Ref # / Investigator 2604
🇺🇸Nederland, Texas, United States
Site Ref # / Investigator 2580
🇺🇸Prairie Village, Kansas, United States
Site Ref # / Investigator 2605
🇺🇸Phoenix, Arizona, United States
Site Ref # / Investigator 1990
🇺🇸Phoenix, Arizona, United States
Site Ref # / Investigator 3421
🇺🇸Las Vegas, Nevada, United States
Site Ref # / Investigator 2206
🇺🇸Las Vegas, Nevada, United States
Site Ref # / Investigator 2218
🇺🇸Cincinnati, Ohio, United States
Site Ref # / Investigator 2211
🇺🇸Oklahoma City, Oklahoma, United States
Site Ref # / Investigator 1981
🇺🇸San Antonio, Texas, United States
Site Ref # / Investigator 2608
🇺🇸San Antonio, Texas, United States
Site Ref # / Investigator 2157
🇺🇸Denver, Colorado, United States
Site Ref # / Investigator 1986
🇺🇸Omaha, Nebraska, United States
Site Ref # / Investigator 1992
🇺🇸Buena Park, California, United States
Site Ref # / Investigator 2216
🇺🇸Hueytown, Alabama, United States
Site Ref # / Investigator 1993
🇺🇸Burbank, California, United States
Site Ref # / Investigator 1989
🇺🇸Los Gatos, California, United States
Site Ref # / Investigator 2219
🇺🇸Fair Oaks, California, United States
Site Ref # / Investigator 2214
🇺🇸Oldsmar, Florida, United States
Site Ref # / Investigator 2135
🇺🇸Plantation, Florida, United States
Site Ref # / Investigator 1975
🇺🇸Atlanta, Georgia, United States
Site Ref # / Investigator 1991
🇺🇸Decatur, Georgia, United States
Site Ref # / Investigator 1985
🇺🇸Chicago, Illinois, United States
Site Ref # / Investigator 1978
🇺🇸Evansville, Indiana, United States
Site Ref # / Investigator 1976
🇺🇸Shreveport, Louisiana, United States
Site Ref # / Investigator 2209
🇺🇸Metairie, Louisiana, United States
Site Ref # / Investigator 2556
🇺🇸Florissant, Missouri, United States
Site Ref # / Investigator 1980
🇺🇸St. Louis, Missouri, United States
Site Ref # / Investigator 1983
🇺🇸Raleigh, North Carolina, United States
Site Ref # / Investigator 2578
🇺🇸Williamsville, New York, United States
Site Ref # / Investigator 2606
🇺🇸Raleigh, North Carolina, United States
Site Ref # / Investigator 1973
🇺🇸New York, New York, United States
Site Ref # / Investigator 1995
🇺🇸Cincinnati, Ohio, United States
Site Ref # / Investigator 1987
🇺🇸Cincinnati, Ohio, United States
Site Ref # / Investigator 2215
🇺🇸Downingtown, Pennsylvania, United States
Site Ref # / Investigator 2579
🇺🇸Duncansville, Pennsylvania, United States
Site Ref # / Investigator 2137
🇺🇸Cranston, Rhode Island, United States
Site Ref # / Investigator 2213
🇺🇸Mechanicsburg, Pennsylvania, United States
Site Ref # / Investigator 2590
🇺🇸Dallas, Texas, United States
Site Ref # / Investigator 2217
🇺🇸Austin, Texas, United States
Site Ref # / Investigator 2117
🇺🇸Killeen, Texas, United States
Site Ref # / Investigator 1979
🇺🇸Richardson, Texas, United States
Site Ref # / Investigator 2220
🇺🇸San Antonio, Texas, United States
Site Ref # / Investigator 2212
🇺🇸San Angelo, Texas, United States
Site Ref # / Investigator 2158
🇺🇸Virginia Beach, Virginia, United States
Site Ref # / Investigator 5161
🇺🇸Winston-Salem, North Carolina, United States
Site Ref # / Investigator 2603
🇺🇸Brockton, Massachusetts, United States
Site Ref # / Investigator 1974
🇺🇸Tempe, Arizona, United States
Site Ref # / Investigator 2208
🇺🇸Clearwater, Florida, United States
Site Ref # / Investigator 2221
🇺🇸Greer, South Carolina, United States
Site Ref # / Investigator 2207
🇺🇸Hollywood, Florida, United States
Site Ref # / Investigator 2156
🇺🇸Wellesley Hills, Massachusetts, United States
Site Ref # / Investigator 3420
🇺🇸Biloxi, Mississippi, United States
Site Ref # / Investigator 1984
🇺🇸Cordova, Tennessee, United States
Site Ref # / Investigator 2134
🇺🇸West Palm Beach, Florida, United States
Site Ref # / Investigator 1977
🇺🇸Tucson, Arizona, United States
Site Ref # / Investigator 1994
🇺🇸Trumbull, Connecticut, United States
Site Ref # / Investigator 2210
🇺🇸DeLand, Florida, United States
Site Ref # / Investigator 2203
🇺🇸Pasadena, Maryland, United States