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A Study of Pain Relief in Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Extended release hydrocodone and acetaminophen (Vicodin CR)
hydrocodone/acetaminophen extended release (Vicodin CR)
placebo
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Ref # / Investigator 2216
  • Site Ref # / Investigator 2605
  • Site Ref # / Investigator 1990
  • Site Ref # / Investigator 1974
  • Site Ref # / Investigator 1977
  • Site Ref # / Investigator 1992
  • Site Ref # / Investigator 1993
  • Site Ref # / Investigator 2219
  • Site Ref # / Investigator 1989
  • Site Ref # / Investigator 2157
  • Site Ref # / Investigator 1994
  • Site Ref # / Investigator 2208
  • Site Ref # / Investigator 2210
  • Site Ref # / Investigator 2207
  • Site Ref # / Investigator 2204
  • Site Ref # / Investigator 2205
  • Site Ref # / Investigator 2214
  • Site Ref # / Investigator 2135
  • Site Ref # / Investigator 2134
  • Site Ref # / Investigator 1975
  • Site Ref # / Investigator 1991
  • Site Ref # / Investigator 1985
  • Site Ref # / Investigator 1978
  • Site Ref # / Investigator 1988
  • Site Ref # / Investigator 2580
  • Site Ref # / Investigator 2209
  • Site Ref # / Investigator 1976
  • Site Ref # / Investigator 2203
  • Site Ref # / Investigator 2603
  • Site Ref # / Investigator 2156
  • Site Ref # / Investigator 3420
  • Site Ref # / Investigator 2556
  • Site Ref # / Investigator 1980
  • Site Ref # / Investigator 1982
  • Site Ref # / Investigator 1986
  • Site Ref # / Investigator 3421
  • Site Ref # / Investigator 2206
  • Site Ref # / Investigator 1973
  • Site Ref # / Investigator 2578
  • Site Ref # / Investigator 1983
  • Site Ref # / Investigator 2606
  • Site Ref # / Investigator 5161
  • Site Ref # / Investigator 2218
  • Site Ref # / Investigator 1995
  • Site Ref # / Investigator 1987
  • Site Ref # / Investigator 2211
  • Site Ref # / Investigator 2215
  • Site Ref # / Investigator 2579
  • Site Ref # / Investigator 2213
  • Site Ref # / Investigator 2137
  • Site Ref # / Investigator 2221
  • Site Ref # / Investigator 1984
  • Site Ref # / Investigator 2217
  • Site Ref # / Investigator 2607
  • Site Ref # / Investigator 2590
  • Site Ref # / Investigator 2117
  • Site Ref # / Investigator 2604
  • Site Ref # / Investigator 1979
  • Site Ref # / Investigator 2212
  • Site Ref # / Investigator 1981
  • Site Ref # / Investigator 2220
  • Site Ref # / Investigator 2608
  • Site Ref # / Investigator 2158

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

arm label (1) hydrocodone/acetaminophen extended release

arm label (2) hydrocodone/acetaminophen extended release

Arm label (3) placebo

Arm Description

Outcomes

Primary Outcome Measures

Pain Intensity Difference from randomization baseline to each subject's final assessment
Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale)

Secondary Outcome Measures

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

Full Information

First Posted
May 11, 2006
Last Updated
July 22, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00325949
Brief Title
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

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
770 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arm label (1) hydrocodone/acetaminophen extended release
Arm Type
Experimental
Arm Title
arm label (2) hydrocodone/acetaminophen extended release
Arm Type
Experimental
Arm Title
Arm label (3) placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Extended release hydrocodone and acetaminophen (Vicodin CR)
Other Intervention Name(s)
hydrocodone / acetaminophen extended release
Intervention Description
2 tablets BID
Intervention Type
Drug
Intervention Name(s)
hydrocodone/acetaminophen extended release (Vicodin CR)
Other Intervention Name(s)
hydrocodone/acetaminophen extended release
Intervention Description
1 tablet BID
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
2 tablets BID
Primary Outcome Measure Information:
Title
Pain Intensity Difference from randomization baseline to each subject's final assessment
Description
Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale)
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period
Title
Pain Intensity Difference from randomization baseline to each scheduled assessment
Title
Global Assessments of Study Drug and Back Pain Status
Title
Roland-Morris Disability Questionnaire

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Jain, M.D.
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Ref # / Investigator 2216
City
Hueytown
State/Province
Alabama
ZIP/Postal Code
35023
Country
United States
Facility Name
Site Ref # / Investigator 2605
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Site Ref # / Investigator 1990
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Site Ref # / Investigator 1974
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Site Ref # / Investigator 1977
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Site Ref # / Investigator 1992
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Site Ref # / Investigator 1993
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Site Ref # / Investigator 2219
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Site Ref # / Investigator 1989
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Site Ref # / Investigator 2157
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Site Ref # / Investigator 1994
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Site Ref # / Investigator 2208
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Site Ref # / Investigator 2210
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Site Ref # / Investigator 2207
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Facility Name
Site Ref # / Investigator 2204
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Site Ref # / Investigator 2205
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Site Ref # / Investigator 2214
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Site Ref # / Investigator 2135
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Site Ref # / Investigator 2134
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409-3509
Country
United States
Facility Name
Site Ref # / Investigator 1975
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Site Ref # / Investigator 1991
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Site Ref # / Investigator 1985
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Site Ref # / Investigator 1978
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Site Ref # / Investigator 1988
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Site Ref # / Investigator 2580
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Site Ref # / Investigator 2209
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Site Ref # / Investigator 1976
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Site Ref # / Investigator 2203
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
Site Ref # / Investigator 2603
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Site Ref # / Investigator 2156
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481-2106
Country
United States
Facility Name
Site Ref # / Investigator 3420
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Site Ref # / Investigator 2556
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Site Ref # / Investigator 1980
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Site Ref # / Investigator 1982
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Site Ref # / Investigator 1986
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Site Ref # / Investigator 3421
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Site Ref # / Investigator 2206
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Site Ref # / Investigator 1973
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Site Ref # / Investigator 2578
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Site Ref # / Investigator 1983
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Site Ref # / Investigator 2606
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site Ref # / Investigator 5161
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site Ref # / Investigator 2218
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Site Ref # / Investigator 1995
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Site Ref # / Investigator 1987
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Site Ref # / Investigator 2211
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Site Ref # / Investigator 2215
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Site Ref # / Investigator 2579
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site Ref # / Investigator 2213
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Site Ref # / Investigator 2137
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Site Ref # / Investigator 2221
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Site Ref # / Investigator 1984
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Site Ref # / Investigator 2217
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Site Ref # / Investigator 2607
City
Bulverde
State/Province
Texas
ZIP/Postal Code
78163
Country
United States
Facility Name
Site Ref # / Investigator 2590
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Site Ref # / Investigator 2117
City
Killeen
State/Province
Texas
ZIP/Postal Code
76543
Country
United States
Facility Name
Site Ref # / Investigator 2604
City
Nederland
State/Province
Texas
ZIP/Postal Code
77627
Country
United States
Facility Name
Site Ref # / Investigator 1979
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Site Ref # / Investigator 2212
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Site Ref # / Investigator 1981
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78127
Country
United States
Facility Name
Site Ref # / Investigator 2220
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Site Ref # / Investigator 2608
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Site Ref # / Investigator 2158
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

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A Study of Pain Relief in Low Back Pain

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