search
Back to results

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# 10143
  • Site Reference ID/Investigator# 10161
  • Site Reference ID/Investigator# 10155
  • Site Reference ID/Investigator# 10160
  • Site Reference ID/Investigator# 10821
  • Site Reference ID/Investigator# 10152
  • Site Reference ID/Investigator# 10157
  • Site Reference ID/Investigator# 10142
  • Site Reference ID/Investigator# 10147
  • Site Reference ID/Investigator# 13821
  • Site Reference ID/Investigator# 15821
  • Site Reference ID/Investigator# 10136
  • Site Reference ID/Investigator# 10822
  • Site Reference ID/Investigator# 10140
  • Site Reference ID/Investigator# 10158
  • Site Reference ID/Investigator# 13601
  • Site Reference ID/Investigator# 10162
  • Site Reference ID/Investigator# 10159
  • Site Reference ID/Investigator# 10126
  • Site Reference ID/Investigator# 10156
  • Site Reference ID/Investigator# 10148
  • Site Reference ID/Investigator# 10151
  • Site Reference ID/Investigator# 10138
  • Site Reference ID/Investigator# 10150
  • Site Reference ID/Investigator# 10141
  • Site Reference ID/Investigator# 10149
  • Site Reference ID/Investigator# 10130
  • Site Reference ID/Investigator# 10163
  • Site Reference ID/Investigator# 13201
  • Site Reference ID/Investigator# 10154
  • Site Reference ID/Investigator# 10144
  • Site Reference ID/Investigator# 10113

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 25, 2008
Last Updated
January 9, 2014
Sponsor
AbbVie (prior sponsor, Abbott)
search

1. Study Identification

Unique Protocol Identification Number
NCT00761150
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
March 2009 (Actual)
Study Completion Date
March 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 was 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
308 (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# 10143
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Site Reference ID/Investigator# 10161
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Site Reference ID/Investigator# 10155
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Site Reference ID/Investigator# 10160
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Site Reference ID/Investigator# 10821
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Site Reference ID/Investigator# 10152
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Site Reference ID/Investigator# 10157
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Site Reference ID/Investigator# 10142
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Site Reference ID/Investigator# 10147
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Site Reference ID/Investigator# 13821
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Site Reference ID/Investigator# 15821
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Site Reference ID/Investigator# 10136
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Site Reference ID/Investigator# 10822
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Site Reference ID/Investigator# 10140
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Site Reference ID/Investigator# 10158
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Site Reference ID/Investigator# 13601
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Site Reference ID/Investigator# 10162
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481-2106
Country
United States
Facility Name
Site Reference ID/Investigator# 10159
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Site Reference ID/Investigator# 10126
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Site Reference ID/Investigator# 10156
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Site Reference ID/Investigator# 10148
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Site Reference ID/Investigator# 10151
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Site Reference ID/Investigator# 10138
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Site Reference ID/Investigator# 10150
City
Perrysburgh
State/Province
Ohio
ZIP/Postal Code
43554
Country
United States
Facility Name
Site Reference ID/Investigator# 10141
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Site Reference ID/Investigator# 10149
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Site Reference ID/Investigator# 10130
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Site Reference ID/Investigator# 10163
City
Killeen
State/Province
Texas
ZIP/Postal Code
76543
Country
United States
Facility Name
Site Reference ID/Investigator# 13201
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209-1744
Country
United States
Facility Name
Site Reference ID/Investigator# 10154
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 10144
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
Facility Name
Site Reference ID/Investigator# 10113
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs