Clinical trial NCT00325949: A Study of Pain Relief in Low Back Pain
Official title: A Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low Back Pain
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-05-15
Enrollment: 770
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity Difference from randomization baseline to each subject's final assessment
timeFrame: 12 Weeks
Secondary outcomes:
measure: Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period
measure: Pain Intensity Difference from randomization baseline to each scheduled assessment
measure: Global Assessments of Study Drug and Back Pain Status
measure: Roland-Morris Disability Questionnaire
Other outcomes:
Locations:
city: Hueytown
country: United States
facility: Site Ref # / Investigator 2216
state: Alabama
city: Phoenix
country: United States
facility: Site Ref # / Investigator 2605
state: Arizona
city: Phoenix
country: United States
facility: Site Ref # / Investigator 1990
state: Arizona
city: Tempe
country: United States
facility: Site Ref # / Investigator 1974
state: Arizona
city: Tucson
country: United States
facility: Site Ref # / Investigator 1977
state: Arizona
city: Buena Park
country: United States
facility: Site Ref # / Investigator 1992
state: California
city: Burbank
country: United States
facility: Site Ref # / Investigator 1993
state: California
city: Fair Oaks
country: United States
facility: Site Ref # / Investigator 2219
state: California
city: Los Gatos
country: United States
facility: Site Ref # / Investigator 1989
state: California
city: Denver
country: United States
facility: Site Ref # / Investigator 2157
state: Colorado
city: Trumbull
country: United States
facility: Site Ref # / Investigator 1994
state: Connecticut
city: Clearwater
country: United States
facility: Site Ref # / Investigator 2208
state: Florida
city: DeLand
country: United States
facility: Site Ref # / Investigator 2210
state: Florida
city: Hollywood
country: United States
facility: Site Ref # / Investigator 2207
state: Florida
city: Miami
country: United States
facility: Site Ref # / Investigator 2204
state: Florida
city: Miami
country: United States
facility: Site Ref # / Investigator 2205
state: Florida
city: Oldsmar
country: United States
facility: Site Ref # / Investigator 2214
state: Florida
city: Plantation
country: United States
facility: Site Ref # / Investigator 2135
state: Florida
city: West Palm Beach
country: United States
facility: Site Ref # / Investigator 2134
state: Florida
city: Atlanta
country: United States
facility: Site Ref # / Investigator 1975
state: Georgia
city: Decatur
country: United States
facility: Site Ref # / Investigator 1991
state: Georgia
city: Chicago
country: United States
facility: Site Ref # / Investigator 1985
state: Illinois
city: Evansville
country: United States
facility: Site Ref # / Investigator 1978
state: Indiana
city: West Des Moines
country: United States
facility: Site Ref # / Investigator 1988
state: Iowa
city: Prairie Village
country: United States
facility: Site Ref # / Investigator 2580
state: Kansas
city: Metairie
country: United States
facility: Site Ref # / Investigator 2209
state: Louisiana
city: Shreveport
country: United States
facility: Site Ref # / Investigator 1976
state: Louisiana
city: Pasadena
country: United States
facility: Site Ref # / Investigator 2203
state: Maryland
city: Brockton
country: United States
facility: Site Ref # / Investigator 2603
state: Massachusetts
city: Wellesley Hills
country: United States
facility: Site Ref # / Investigator 2156
state: Massachusetts
city: Biloxi
country: United States
facility: Site Ref # / Investigator 3420
state: Mississippi
city: Florissant
country: United States
facility: Site Ref # / Investigator 2556
state: Missouri
city: St. Louis
country: United States
facility: Site Ref # / Investigator 1980
state: Missouri
city: Missoula
country: United States
facility: Site Ref # / Investigator 1982
state: Montana
city: Omaha
country: United States
facility: Site Ref # / Investigator 1986
state: Nebraska
city: Las Vegas
country: United States
facility: Site Ref # / Investigator 3421
state: Nevada
city: Las Vegas
country: United States
facility: Site Ref # / Investigator 2206
state: Nevada
city: New York
country: United States
facility: Site Ref # / Investigator 1973
state: New York
city: Williamsville
country: United States
facility: Site Ref # / Investigator 2578
state: New York
city: Raleigh
country: United States
facility: Site Ref # / Investigator 1983
state: North Carolina
city: Raleigh
country: United States
facility: Site Ref # / Investigator 2606
state: North Carolina
city: Winston-Salem
country: United States
facility: Site Ref # / Investigator 5161
state: North Carolina
city: Cincinnati
country: United States
facility: Site Ref # / Investigator 2218
state: Ohio
city: Cincinnati
country: United States
facility: Site Ref # / Investigator 1995
state: Ohio
city: Cincinnati
country: United States
facility: Site Ref # / Investigator 1987
state: Ohio
city: Oklahoma City
country: United States
facility: Site Ref # / Investigator 2211
state: Oklahoma
city: Downingtown
country: United States
facility: Site Ref # / Investigator 2215
state: Pennsylvania
city: Duncansville
country: United States
facility: Site Ref # / Investigator 2579
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Site Ref # / Investigator 2213
state: Pennsylvania
city: Cranston
country: United States
facility: Site Ref # / Investigator 2137
state: Rhode Island
city: Greer
country: United States
facility: Site Ref # / Investigator 2221
state: South Carolina
city: Cordova
country: United States
facility: Site Ref # / Investigator 1984
state: Tennessee
city: Austin
country: United States
facility: Site Ref # / Investigator 2217
state: Texas
city: Bulverde
country: United States
facility: Site Ref # / Investigator 2607
state: Texas
city: Dallas
country: United States
facility: Site Ref # / Investigator 2590
state: Texas
city: Killeen
country: United States
facility: Site Ref # / Investigator 2117
state: Texas
city: Nederland
country: United States
facility: Site Ref # / Investigator 2604
state: Texas
city: Richardson
country: United States
facility: Site Ref # / Investigator 1979
state: Texas
city: San Angelo
country: United States
facility: Site Ref # / Investigator 2212
state: Texas
city: San Antonio
country: United States
facility: Site Ref # / Investigator 1981
state: Texas
city: San Antonio
country: United States
facility: Site Ref # / Investigator 2220
state: Texas
city: San Antonio
country: United States
facility: Site Ref # / Investigator 2608
state: Texas
city: Virginia Beach
country: United States
facility: Site Ref # / Investigator 2158
state: Virginia
Study officials:
affiliation: Abbott
name: Rita Jain, M.D.
role: STUDY_DIRECTOR
References: