Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
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
1 other identifier
interventional
308
1 country
32
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2008
Shorter than P25 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
December 23, 2013
CompletedFebruary 7, 2014
January 1, 2014
6 months
September 25, 2008
November 1, 2013
January 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Double-blind baseline to 4 weeks
Secondary Outcomes (1)
Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
Double-blind baseline to 4 weeks
Study Arms (3)
Open-label ABT-712
EXPERIMENTAL2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
Double-blind ABT-712
EXPERIMENTAL2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
Double-blind Placebo
PLACEBO COMPARATOR2 placebo tablets, twice daily, for 4 weeks (double-blind period).
Interventions
Eligibility Criteria
You may qualify if:
- Adult male and female subjects who voluntarily sign the informed consent
- Diagnosis of CLBP of 6 months duration
You may not qualify if:
- Incapacitated or bedridden subjects
- Subjects with history of surgical or invasive intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Site Reference ID/Investigator# 10143
Tempe, Arizona, 85282, United States
Site Reference ID/Investigator# 10161
Tempe, Arizona, 85282, United States
Site Reference ID/Investigator# 10155
Tucson, Arizona, 85741, United States
Site Reference ID/Investigator# 10160
Anaheim, California, 92801, United States
Site Reference ID/Investigator# 10821
Lomita, California, 90717, United States
Site Reference ID/Investigator# 10152
Clearwater, Florida, 33765, United States
Site Reference ID/Investigator# 10157
DeLand, Florida, 32720, United States
Site Reference ID/Investigator# 10142
Oldsmar, Florida, 34677, United States
Site Reference ID/Investigator# 10147
Pembroke Pines, Florida, 33024, United States
Site Reference ID/Investigator# 13821
Plantation, Florida, 33324, United States
Site Reference ID/Investigator# 15821
Chicago, Illinois, 60611, United States
Site Reference ID/Investigator# 10136
Crestview Hills, Kentucky, 41017, United States
Site Reference ID/Investigator# 10822
New Orleans, Louisiana, 70114, United States
Site Reference ID/Investigator# 10140
Shreveport, Louisiana, 71103, United States
Site Reference ID/Investigator# 10158
Brockton, Massachusetts, 02301, United States
Site Reference ID/Investigator# 13601
Fall River, Massachusetts, 02720, United States
Site Reference ID/Investigator# 10162
Wellesley Hills, Massachusetts, 02481-2106, United States
Site Reference ID/Investigator# 10159
Omaha, Nebraska, 68134, United States
Site Reference ID/Investigator# 10126
Las Vegas, Nevada, 89144, United States
Site Reference ID/Investigator# 10156
Cincinnati, Ohio, 45227, United States
Site Reference ID/Investigator# 10148
Cincinnati, Ohio, 45242, United States
Site Reference ID/Investigator# 10151
Kettering, Ohio, 45429, United States
Site Reference ID/Investigator# 10138
Marion, Ohio, 43302, United States
Site Reference ID/Investigator# 10150
Perrysburg, Ohio, 43554, United States
Site Reference ID/Investigator# 10141
Dallas, Texas, 75251, United States
Site Reference ID/Investigator# 10149
El Paso, Texas, 79902, United States
Site Reference ID/Investigator# 10130
Fort Worth, Texas, 76135, United States
Site Reference ID/Investigator# 10163
Killeen, Texas, 76543, United States
Site Reference ID/Investigator# 13201
San Antonio, Texas, 78209-1744, United States
Site Reference ID/Investigator# 10154
San Antonio, Texas, 78229, United States
Site Reference ID/Investigator# 10144
Roanoke, Virginia, 24018, United States
Site Reference ID/Investigator# 10113
Spokane, Washington, 99204, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie (prior sponsor, Abbott)
Study Officials
- STUDY DIRECTOR
Pedro Quintana Diez, MD
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 29, 2008
Study Start
September 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
February 7, 2014
Results First Posted
December 23, 2013
Record last verified: 2014-01