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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label ABT-712 | Experimental | 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). |
|
| Double-blind ABT-712 | Experimental | 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). |
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| Double-blind Placebo | Placebo Comparator | 2 placebo tablets, twice daily, for 4 weeks (double-blind period). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-712 | Drug | ABT-712 extended-release tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Quintana Diez, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 10143 | Tempe | Arizona | 85282 | United States | ||
| Site Reference ID/Investigator# 10161 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label ABT-712 | 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). |
| FG001 | Double-blind ABT-712 | 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label Period |
|
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| Placebo | Drug | Placebo tablet |
|
| Double-blind baseline to 4 weeks |
| 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 |
| FG002 | Double-blind Placebo | 2 placebo tablets, twice daily, for 4 weeks (double-blind period). |
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| NOT COMPLETED |
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| Double-blind Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nonrandomized | 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period. |
| BG001 | Double-blind ABT-712 | 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). |
| BG002 | Double-blind Placebo | 2 placebo tablets, twice daily, for 4 weeks (double-blind period). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Double-blind Baseline CLBP Intensity VAS | The last assessment using the CLBP Intensity Visual Analog Scale (VAS) (0 mm = No Pain and 100 mm = Worst Pain Imaginable) conducted before the first dose in the double-blind period. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Double-blind Baseline Sleep Interference by Pain Scale | The last assessment of how much back pain interfered with their sleep on a scale of 0 (not at all) to 10 (completely) conducted before the first dose in the double-blind period. | Mean | Standard Deviation | scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat). | Posted | Least Squares Mean | Standard Error | scores on a scale | Double-blind baseline to 4 weeks |
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| ||||||||||||||||||||||||||||
| Secondary | 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. | The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period. | Posted | Least Squares Mean | Standard Error | scores on a scale | Double-blind baseline to 4 weeks |
|
AEs were recorded from the time of study drug administration to 30 days after last dose (total 12 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 16 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (ABT-712 or placebo) in the DB period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-label ABT-712 | 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). | 1 | 308 | 169 | 308 | ||
| EG001 | Double-blind ABT-712 | 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). | 0 | 120 | 18 | 120 | ||
| EG002 | Double-blind Placebo | 2 placebo tablets, twice daily, for 4 weeks (double-blind period). | 2 | 118 | 19 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIVERTICULAR PERFORATION | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 11.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D006853 | Hydrocodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Did not meet DB randomization criteria |
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| Noncompliance |
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| Other |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
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