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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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ClinicalTrials.gov Identifier: NCT00761150
Recruitment Status : Completed
First Posted : September 29, 2008
Results First Posted : December 23, 2013
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Low Back Pain
Interventions Drug: ABT-712
Drug: Placebo
Enrollment 308

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-label ABT-712 Double-blind ABT-712 Double-blind Placebo
Hide Arm/Group 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).
Period Title: Open-label Period
Started 308 0 0
Completed 238 0 0
Not Completed 70 0 0
Reason Not Completed
Adverse Event             36             0             0
Did not meet DB randomization criteria             11             0             0
Lost to Follow-up             7             0             0
Lack of Efficacy             4             0             0
Withdrawal by Subject             5             0             0
Noncompliance             2             0             0
Not specified             5             0             0
Period Title: Double-blind Period
Started 0 120 118
Completed 0 106 89
Not Completed 0 14 29
Reason Not Completed
Lack of Efficacy             0             2             19
Adverse Event             0             3             3
Withdrawal by Subject             0             3             2
Lost to Follow-up             0             2             1
Did not meet DB randomization criteria             0             0             1
Noncompliance             0             1             0
Not specified             0             3             3
Arm/Group Title Nonrandomized Double-blind ABT-712 Double-blind Placebo Total
Hide Arm/Group Description 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. 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). Total of all reporting groups
Overall Number of Baseline Participants 70 120 118 308
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 120 participants 118 participants 308 participants
51.3  (12.31) 48.1  (12.64) 48.4  (12.24) 49.0  (12.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 120 participants 118 participants 308 participants
Female
43
  61.4%
66
  55.0%
78
  66.1%
187
  60.7%
Male
27
  38.6%
54
  45.0%
40
  33.9%
121
  39.3%
Double-blind Baseline CLBP Intensity VAS   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 70 participants 120 participants 118 participants 308 participants
NA [2]   (NA) 22.4  (15.25) 22.9  (14.86) 22.6  (15.03)
[1]
Measure Description: 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.
[2]
These subjects were not randomized to the double-blind period.
Double-blind Baseline Sleep Interference by Pain Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 70 participants 120 participants 118 participants 308 participants
NA [2]   (NA) 2.2  (2.01) 2.1  (1.82) 2.2  (1.91)
[1]
Measure Description: 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.
[2]
These subjects were not randomized to the double-blind period.
1.Primary Outcome
Title Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Double-blind ABT-712 Double-blind Placebo
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 120 118
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
1.1  (2.41) 18.0  (2.43)
2.Secondary Outcome
Title Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Double-blind ABT-712 Double-blind Placebo
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 116 113
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Trouble Falling Asleep -4.8  (2.43) 13.1  (2.48)
Needed Sleeping Medication -1.6  (2.04) 8.4  (2.09)
Awakened by Pain During the Night -0.5  (2.52) 15.1  (2.57)
Awakened by Pain in the Morning 0.3  (2.62) 13.0  (2.67)
Quality of Sleep 0.1  (2.59) -13.9  (2.66)
Time Frame 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).
Adverse Event Reporting Description 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.
 
Arm/Group Title Open-label ABT-712 Double-blind ABT-712 Double-blind Placebo
Hide Arm/Group 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).
All-Cause Mortality
Open-label ABT-712 Double-blind ABT-712 Double-blind Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open-label ABT-712 Double-blind ABT-712 Double-blind Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/308 (0.32%)   0/120 (0.00%)   2/118 (1.69%) 
Gastrointestinal disorders       
DIVERTICULAR PERFORATION  1  1/308 (0.32%)  0/120 (0.00%)  0/118 (0.00%) 
Psychiatric disorders       
ANXIETY  1  0/308 (0.00%)  0/120 (0.00%)  1/118 (0.85%) 
DEPRESSION  1  0/308 (0.00%)  0/120 (0.00%)  1/118 (0.85%) 
Respiratory, thoracic and mediastinal disorders       
PULMONARY EMBOLISM  1  0/308 (0.00%)  0/120 (0.00%)  1/118 (0.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-label ABT-712 Double-blind ABT-712 Double-blind Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   169/308 (54.87%)   18/120 (15.00%)   19/118 (16.10%) 
Gastrointestinal disorders       
CONSTIPATION  1  84/308 (27.27%)  5/120 (4.17%)  4/118 (3.39%) 
NAUSEA  1  78/308 (25.32%)  8/120 (6.67%)  2/118 (1.69%) 
VOMITING  1  21/308 (6.82%)  4/120 (3.33%)  2/118 (1.69%) 
Nervous system disorders       
DIZZINESS  1  23/308 (7.47%)  1/120 (0.83%)  2/118 (1.69%) 
HEADACHE  1  28/308 (9.09%)  7/120 (5.83%)  13/118 (11.02%) 
SOMNOLENCE  1  32/308 (10.39%)  1/120 (0.83%)  1/118 (0.85%) 
Skin and subcutaneous tissue disorders       
PRURITUS  1  20/308 (6.49%)  0/120 (0.00%)  0/118 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00761150     History of Changes
Other Study ID Numbers: M10-385
First Submitted: September 25, 2008
First Posted: September 29, 2008
Results First Submitted: November 1, 2013
Results First Posted: December 23, 2013
Last Update Posted: February 7, 2014