Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) (NCT NCT00761150)
NCT ID: NCT00761150
Last Updated: 2014-02-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
308 participants
Primary outcome timeframe
Double-blind baseline to 4 weeks
Results posted on
2014-02-07
Participant Flow
Participant milestones
| Measure |
Open-label ABT-712
2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
|
Double-blind ABT-712
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
|
Double-blind Placebo
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
|
|---|---|---|---|
|
Open-label Period
STARTED
|
308
|
0
|
0
|
|
Open-label Period
COMPLETED
|
238
|
0
|
0
|
|
Open-label Period
NOT COMPLETED
|
70
|
0
|
0
|
|
Double-blind Period
STARTED
|
0
|
120
|
118
|
|
Double-blind Period
COMPLETED
|
0
|
106
|
89
|
|
Double-blind Period
NOT COMPLETED
|
0
|
14
|
29
|
Reasons for withdrawal
| Measure |
Open-label ABT-712
2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
|
Double-blind ABT-712
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
|
Double-blind Placebo
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
|
|---|---|---|---|
|
Open-label Period
Adverse Event
|
36
|
0
|
0
|
|
Open-label Period
Did not meet DB randomization criteria
|
11
|
0
|
0
|
|
Open-label Period
Lost to Follow-up
|
7
|
0
|
0
|
|
Open-label Period
Lack of Efficacy
|
4
|
0
|
0
|
|
Open-label Period
Withdrawal by Subject
|
5
|
0
|
0
|
|
Open-label Period
Noncompliance
|
2
|
0
|
0
|
|
Open-label Period
Other
|
5
|
0
|
0
|
|
Double-blind Period
Lack of Efficacy
|
0
|
2
|
19
|
|
Double-blind Period
Adverse Event
|
0
|
3
|
3
|
|
Double-blind Period
Withdrawal by Subject
|
0
|
3
|
2
|
|
Double-blind Period
Lost to Follow-up
|
0
|
2
|
1
|
|
Double-blind Period
Did not meet DB randomization criteria
|
0
|
0
|
1
|
|
Double-blind Period
Noncompliance
|
0
|
1
|
0
|
|
Double-blind Period
Other
|
0
|
3
|
3
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Baseline characteristics by cohort
| Measure |
Nonrandomized
n=70 Participants
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.
|
Double-blind ABT-712
n=120 Participants
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
|
Double-blind Placebo
n=118 Participants
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 12.31 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 12.64 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 12.24 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 12.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
187 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Double-blind Baseline CLBP Intensity VAS
|
NA scores on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
22.4 scores on a scale
STANDARD_DEVIATION 15.25 • n=7 Participants
|
22.9 scores on a scale
STANDARD_DEVIATION 14.86 • n=5 Participants
|
22.6 scores on a scale
STANDARD_DEVIATION 15.03 • n=4 Participants
|
|
Double-blind Baseline Sleep Interference by Pain Scale
|
NA scores on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
2.2 scores on a scale
STANDARD_DEVIATION 2.01 • n=7 Participants
|
2.1 scores on a scale
STANDARD_DEVIATION 1.82 • n=5 Participants
|
2.2 scores on a scale
STANDARD_DEVIATION 1.91 • n=4 Participants
|
PRIMARY outcome
Timeframe: Double-blind baseline to 4 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Double-blind ABT-712
n=120 Participants
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
|
Double-blind Placebo
n=118 Participants
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
|
|---|---|---|
|
Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
|
1.1 scores on a scale
Standard Error 2.41
|
18.0 scores on a scale
Standard Error 2.43
|
SECONDARY outcome
Timeframe: Double-blind baseline to 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Double-blind ABT-712
n=116 Participants
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
|
Double-blind Placebo
n=113 Participants
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
|
|---|---|---|
|
Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
Trouble Falling Asleep
|
-4.8 scores on a scale
Standard Error 2.43
|
13.1 scores on a scale
Standard Error 2.48
|
|
Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
Needed Sleeping Medication
|
-1.6 scores on a scale
Standard Error 2.04
|
8.4 scores on a scale
Standard Error 2.09
|
|
Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
Awakened by Pain During the Night
|
-0.5 scores on a scale
Standard Error 2.52
|
15.1 scores on a scale
Standard Error 2.57
|
|
Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
Awakened by Pain in the Morning
|
0.3 scores on a scale
Standard Error 2.62
|
13.0 scores on a scale
Standard Error 2.67
|
|
Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
Quality of Sleep
|
0.1 scores on a scale
Standard Error 2.59
|
-13.9 scores on a scale
Standard Error 2.66
|
Adverse Events
Open-label ABT-712
Serious events: 1 serious events
Other events: 169 other events
Deaths: 0 deaths
Double-blind ABT-712
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Double-blind Placebo
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label ABT-712
n=308 participants at risk
2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
|
Double-blind ABT-712
n=120 participants at risk
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
|
Double-blind Placebo
n=118 participants at risk
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
|
|---|---|---|---|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.32%
1/308 • 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.
|
0.00%
0/120 • 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.
|
0.00%
0/118 • 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.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/308 • 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.
|
0.00%
0/120 • 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.
|
0.85%
1/118 • 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.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/308 • 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.
|
0.00%
0/120 • 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.
|
0.85%
1/118 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/308 • 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.
|
0.00%
0/120 • 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.
|
0.85%
1/118 • 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.
|
Other adverse events
| Measure |
Open-label ABT-712
n=308 participants at risk
2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
|
Double-blind ABT-712
n=120 participants at risk
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
|
Double-blind Placebo
n=118 participants at risk
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
|
|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
27.3%
84/308 • 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.
|
4.2%
5/120 • 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.
|
3.4%
4/118 • 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.
|
|
Gastrointestinal disorders
NAUSEA
|
25.3%
78/308 • 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.
|
6.7%
8/120 • 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.
|
1.7%
2/118 • 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.
|
|
Gastrointestinal disorders
VOMITING
|
6.8%
21/308 • 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.
|
3.3%
4/120 • 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.
|
1.7%
2/118 • 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.
|
|
Nervous system disorders
DIZZINESS
|
7.5%
23/308 • 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.
|
0.83%
1/120 • 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.
|
1.7%
2/118 • 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.
|
|
Nervous system disorders
HEADACHE
|
9.1%
28/308 • 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.
|
5.8%
7/120 • 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.
|
11.0%
13/118 • 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.
|
|
Nervous system disorders
SOMNOLENCE
|
10.4%
32/308 • 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.
|
0.83%
1/120 • 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.
|
0.85%
1/118 • 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.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.5%
20/308 • 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.
|
0.00%
0/120 • 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.
|
0.00%
0/118 • 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.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER