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Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABT-712
Placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Effect on sleep interference by pain

Eligibility Criteria

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

Inclusion Criteria:

  • Adult male and female subjects who voluntarily sign the informed consent
  • Diagnosis of CLBP of 6 months duration

Exclusion Criteria:

  • Incapacitated or bedridden subjects
  • Subjects with history of surgical or invasive intervention

Sites / Locations

  • Site Reference ID/Investigator# 10044
  • Site Reference ID/Investigator# 10070
  • Site Reference ID/Investigator# 10050
  • Site Reference ID/Investigator# 10060
  • Site Reference ID/Investigator# 10069
  • Site Reference ID/Investigator# 10045
  • Site Reference ID/Investigator# 10061
  • Site Reference ID/Investigator# 10054
  • Site Reference ID/Investigator# 10071
  • Site Reference ID/Investigator# 13604
  • Site Reference ID/Investigator# 10053
  • Site Reference ID/Investigator# 10055
  • Site Reference ID/Investigator# 10043
  • Site Reference ID/Investigator# 10072
  • Site Reference ID/Investigator# 10041
  • Site Reference ID/Investigator# 10049
  • Site Reference ID/Investigator# 10062
  • Site Reference ID/Investigator# 10066
  • Site Reference ID/Investigator# 10073
  • Site Reference ID/Investigator# 10056
  • Site Reference ID/Investigator# 10075
  • Site Reference ID/Investigator# 10065
  • Site Reference ID/Investigator# 10067
  • Site Reference ID/Investigator# 10047
  • Site Reference ID/Investigator# 10052
  • Site Reference ID/Investigator# 10042
  • Site Reference ID/Investigator# 10063
  • Site Reference ID/Investigator# 10046
  • Site Reference ID/Investigator# 10058
  • Site Reference ID/Investigator# 10059
  • Site Reference ID/Investigator# 10048

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Open-label ABT-712

Double-blind ABT-712

Double-blind Placebo

Arm Description

2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).

2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).

2 placebo tablets, twice daily, for 4 weeks (double-blind period).

Outcomes

Primary Outcome Measures

Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.

Secondary Outcome Measures

Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.

Full Information

First Posted
September 26, 2008
Last Updated
January 8, 2014
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT00763321
Brief Title
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Official Title
A Phase 3, Open-Label Period Followed by a Randomized, Double-blind Placebo-controlled Study of the Analgesic Efficacy 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
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).
Detailed Description
The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Effect on sleep interference by pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label ABT-712
Arm Type
Experimental
Arm Description
2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
Arm Title
Double-blind ABT-712
Arm Type
Experimental
Arm Description
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
Arm Title
Double-blind Placebo
Arm Type
Placebo Comparator
Arm Description
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
Intervention Type
Drug
Intervention Name(s)
ABT-712
Other Intervention Name(s)
Hydrocodone and acetaminophen extended-release, Hydrocodone bitartrate and acetaminophen extended-release
Intervention Description
ABT-712 extended-release tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
Description
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.
Time Frame
Double-blind baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
Description
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.
Time Frame
Double-blind baseline to 4 weeks

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: Adult male and female subjects who voluntarily sign the informed consent Diagnosis of CLBP of 6 months duration Exclusion Criteria: Incapacitated or bedridden subjects Subjects with history of surgical or invasive intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Quintana Diez, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 10044
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Site Reference ID/Investigator# 10070
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Site Reference ID/Investigator# 10050
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Site Reference ID/Investigator# 10060
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Site Reference ID/Investigator# 10069
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Facility Name
Site Reference ID/Investigator# 10045
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
347411
Country
United States
Facility Name
Site Reference ID/Investigator# 10061
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Site Reference ID/Investigator# 10054
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Site Reference ID/Investigator# 10071
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Site Reference ID/Investigator# 13604
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Site Reference ID/Investigator# 10053
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Site Reference ID/Investigator# 10055
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Site Reference ID/Investigator# 10043
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Site Reference ID/Investigator# 10072
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Site Reference ID/Investigator# 10041
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
Site Reference ID/Investigator# 10049
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Site Reference ID/Investigator# 10062
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Site Reference ID/Investigator# 10066
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Site Reference ID/Investigator# 10073
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Site Reference ID/Investigator# 10056
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Site Reference ID/Investigator# 10075
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Site Reference ID/Investigator# 10065
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site Reference ID/Investigator# 10067
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Site Reference ID/Investigator# 10047
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Site Reference ID/Investigator# 10052
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Site Reference ID/Investigator# 10042
City
Bridgeville
State/Province
Pennsylvania
ZIP/Postal Code
15017
Country
United States
Facility Name
Site Reference ID/Investigator# 10063
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Site Reference ID/Investigator# 10046
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Site Reference ID/Investigator# 10058
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Site Reference ID/Investigator# 10059
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Site Reference ID/Investigator# 10048
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States

12. IPD Sharing Statement

Links:
URL
http://rxabbvie.com
Description
Related Info

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Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)

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