Phase 2 Chronic Low Back Pain Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01364922
First received: June 1, 2011
Last updated: December 23, 2013
Last verified: December 2013
Results First Received: November 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Low Back Pain
Interventions: Drug: hydrocodone/acetaminophen extended release
Drug: Placebo

  Participant Flow
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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 Hydrocodone/Acetaminophen Extended Release 2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks.
Double-blind Hydrocodone/Acetaminophen Extended Release 1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
Double-blind Placebo 1 placebo tablet, twice daily, for 2 weeks.

Participant Flow for 2 periods

Period 1:   Open-label (OL) Period
    Open-label Hydrocodone/Acetaminophen Extended Release     Double-blind Hydrocodone/Acetaminophen Extended Release     Double-blind Placebo  
STARTED     168     0     0  
COMPLETED     146     0     0  
NOT COMPLETED     22     0     0  
Adverse Event                 7                 0                 0  
Did Not Meet Randomization Criteria                 6                 0                 0  
Withdrawal by Subject                 4                 0                 0  
Lack of Efficacy                 3                 0                 0  
Lost to Follow-up                 1                 0                 0  
Other, Unspecified                 1                 0                 0  

Period 2:   Double-Blind (DB) Period
    Open-label Hydrocodone/Acetaminophen Extended Release     Double-blind Hydrocodone/Acetaminophen Extended Release     Double-blind Placebo  
STARTED     0     99     47  
COMPLETED     0     94     42  
NOT COMPLETED     0     5     5  
Lack of Efficacy                 0                 3                 4  
Subject Noncompliant                 0                 1                 0  
Adverse Event                 0                 0                 1  
Other, Unspecified                 0                 1                 0  



  Baseline Characteristics
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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
OL Hydrocodone/Acetaminophen Extended Release (Nonrandomized) 2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period; these participants were not randomized and did not progress to the double-blind period.
DB Hydrocodone/Acetaminophen Extended Release 1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
DB Placebo 1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
Total Total of all reporting groups

Baseline Measures
    OL Hydrocodone/Acetaminophen Extended Release (Nonrandomized)     DB Hydrocodone/Acetaminophen Extended Release     DB Placebo     Total  
Number of Participants  
[units: participants]
  22     99     47     168  
Age  
[units: years]
Mean ± Standard Deviation
  51.0  ± 13.82     47.9  ± 13.62     52.7  ± 13.82     49.7  ± 13.79  
Gender  
[units: participants]
       
Female     15     61     30     106  
Male     7     38     17     62  
Double-blind Baseline Chronic Lower Back Pain (CLBP) Intensity VAS [1]
[units: scores on a scale]
Mean ± Standard Deviation
  NA  ± NA [2]   26.9  ± 13.78     31.7  ± 11.17     28.5  ± 13.14  
Double-blind Participant's Global Assessment of Back Pain Status [3]
[units: participants]
       
Fair     NA [2]   21     14     NA [4]
Good     NA [2]   57     29     NA [4]
Poor     NA [2]   2     0     NA [4]
Very Good     NA [2]   15     3     NA [4]
[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.
[3] Participant answered the question "Considering all the ways your chronic low back pain affects you, how are you doing today?" on a 5-point scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Values presented for all participants with double-blind baseline data.
[4] Total not calculated because data are not available (NA) in one or more arms.



  Outcome Measures
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1.  Primary:   Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)   [ Time Frame: Double-blind baseline to Day 29 ]

2.  Secondary:   Participant’s Global Assessment of Back Pain Status at Final Evaluation   [ Time Frame: Double-blind baseline to Day 29 ]

3.  Secondary:   Participant’s Global Assessment of Study Drug at Final Evaluation   [ Time Frame: Double-blind baseline to Day 29 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01364922     History of Changes
Other Study ID Numbers: M12-807
Study First Received: June 1, 2011
Results First Received: November 1, 2013
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration