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Trial record 52 of 145 for:    Hydrocodone

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).

Participant Flow for 2 periods

Period 1:   Open-label Period
    Open-label ABT-712   Double-blind ABT-712   Double-blind Placebo
STARTED   308   0   0 
COMPLETED   238   0   0 
NOT COMPLETED   70   0   0 
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 2:   Double-blind Period
    Open-label ABT-712   Double-blind ABT-712   Double-blind Placebo
STARTED   0   120   118 
COMPLETED   0   106   89 
NOT COMPLETED   0   14   29 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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).
Total Total of all reporting groups

Baseline Measures
   Nonrandomized   Double-blind ABT-712   Double-blind Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   120   118   308 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.3  (12.31)   48.1  (12.64)   48.4  (12.24)   49.0  (12.44) 
Gender 
[Units: Participants]
       
Female   43   66   78   187 
Male   27   54   40   121 
Double-blind Baseline CLBP Intensity VAS [1] [2] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 NA [2]   22.4  (15.25)   22.9  (14.86)   22.6  (15.03) 
[1] 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] [2] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 NA [2]   2.2  (2.01)   2.1  (1.82)   2.2  (1.91) 
[1] 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.


  Outcome Measures

1.  Primary:   Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)   [ Time Frame: Double-blind baseline to 4 weeks ]

2.  Secondary:   Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)   [ Time Frame: Double-blind baseline to 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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