Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
770 participants
INTERVENTIONAL
2006-05-31
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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arm label (1) hydrocodone/acetaminophen extended release
Extended release hydrocodone and acetaminophen (Vicodin CR)
2 tablets BID
arm label (2) hydrocodone/acetaminophen extended release
hydrocodone/acetaminophen extended release (Vicodin CR)
1 tablet BID
Arm label (3) placebo
placebo
2 tablets BID
Interventions
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Extended release hydrocodone and acetaminophen (Vicodin CR)
2 tablets BID
hydrocodone/acetaminophen extended release (Vicodin CR)
1 tablet BID
placebo
2 tablets BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
75 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott Laboratories
Principal Investigators
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Rita Jain, M.D.
Role: STUDY_DIRECTOR
Abbott
Locations
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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
Site Ref # / Investigator 1994
Trumbull, Connecticut, United States
Site Ref # / Investigator 2208
Clearwater, Florida, United States
Site Ref # / Investigator 2210
DeLand, Florida, United States
Site Ref # / Investigator 2207
Hollywood, Florida, United States
Site Ref # / Investigator 2204
Miami, Florida, United States
Site Ref # / Investigator 2205
Miami, Florida, United States
Site Ref # / Investigator 2214
Oldsmar, Florida, United States
Site Ref # / Investigator 2135
Plantation, Florida, United States
Site Ref # / Investigator 2134
West Palm Beach, 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 1988
West Des Moines, Iowa, United States
Site Ref # / Investigator 2580
Prairie Village, Kansas, United States
Site Ref # / Investigator 2209
Metairie, Louisiana, United States
Site Ref # / Investigator 1976
Shreveport, Louisiana, United States
Site Ref # / Investigator 2203
Pasadena, Maryland, United States
Site Ref # / Investigator 2603
Brockton, Massachusetts, United States
Site Ref # / Investigator 2156
Wellesley Hills, Massachusetts, United States
Site Ref # / Investigator 3420
Biloxi, Mississippi, United States
Site Ref # / Investigator 2556
Florissant, Missouri, United States
Site Ref # / Investigator 1980
St Louis, Missouri, United States
Site Ref # / Investigator 1982
Missoula, Montana, United States
Site Ref # / Investigator 1986
Omaha, Nebraska, United States
Site Ref # / Investigator 3421
Las Vegas, Nevada, United States
Site Ref # / Investigator 2206
Las Vegas, Nevada, United States
Site Ref # / Investigator 1973
New York, New York, United States
Site Ref # / Investigator 2578
Williamsville, New York, United States
Site Ref # / Investigator 1983
Raleigh, North Carolina, United States
Site Ref # / Investigator 2606
Raleigh, North Carolina, United States
Site Ref # / Investigator 5161
Winston-Salem, North Carolina, United States
Site Ref # / Investigator 2218
Cincinnati, Ohio, United States
Site Ref # / Investigator 1995
Cincinnati, Ohio, United States
Site Ref # / Investigator 1987
Cincinnati, Ohio, United States
Site Ref # / Investigator 2211
Oklahoma City, Oklahoma, United States
Site Ref # / Investigator 2215
Downingtown, Pennsylvania, United States
Site Ref # / Investigator 2579
Duncansville, Pennsylvania, United States
Site Ref # / Investigator 2213
Mechanicsburg, Pennsylvania, United States
Site Ref # / Investigator 2137
Cranston, Rhode Island, United States
Site Ref # / Investigator 2221
Greer, South Carolina, United States
Site Ref # / Investigator 1984
Cordova, Tennessee, United States
Site Ref # / Investigator 2217
Austin, Texas, United States
Site Ref # / Investigator 2607
Bulverde, Texas, United States
Site Ref # / Investigator 2590
Dallas, Texas, United States
Site Ref # / Investigator 2117
Killeen, Texas, United States
Site Ref # / Investigator 2604
Nederland, Texas, United States
Site Ref # / Investigator 1979
Richardson, Texas, United States
Site Ref # / Investigator 2212
San Angelo, Texas, United States
Site Ref # / Investigator 1981
San Antonio, Texas, United States
Site Ref # / Investigator 2220
San Antonio, Texas, United States
Site Ref # / Investigator 2608
San Antonio, Texas, United States
Site Ref # / Investigator 2158
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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M05-790
Identifier Type: -
Identifier Source: org_study_id
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