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Study of the Insomnia in Patients With Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00365976
First received: August 16, 2006
Last updated: July 11, 2014
Last verified: March 2013
Results First Received: March 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Primary Insomnia
Interventions: Drug: Eszopiclone
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
Seventy adult volunteers with low back pain who met diagnostic criteria for insomnia were recruited through newspaper advertisements, posted announcements and physician referrals. Of those 70, 10 did not meet inclusion criteria, and 2 chose not to participate. The remaining 58 were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Qualifying subjects were switched from their current pain regimen to naproxen and lansoprazole. We excluded those with: significant medical or neurological illness other than LBP; psychiatric disease impacting sleep; substance abuse; history of hypersensitivity or contraindication to NAP/LAN or ESZ; abnormalities on baseline laboratory tests.

Reporting Groups
  Description
Eszopiclone Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo Placebo : Placebo nightly over duration of double blind study phase.

Participant Flow:   Overall Study
    Eszopiclone     Placebo  
STARTED     33     25  
COMPLETED     32     20  
NOT COMPLETED     1     5  
Withdrawal by Subject                 1                 5  



  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
Eszopiclone Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo Placebo : Placebo nightly over duration of double blind study phase.
Total Total of all reporting groups

Baseline Measures
    Eszopiclone     Placebo     Total  
Number of Participants  
[units: participants]
  33     25     58  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     33     25     58  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45.7  ± 11.0     40.1  ± 12.8     43.5  ± 11.7  
Gender  
[units: participants]
     
Female     20     18     38  
Male     13     7     20  
Region of Enrollment  
[units: participants]
     
United States     33     25     58  



  Outcome Measures

1.  Primary:   Mean Subjective Sleep Diary Derived Total Sleep Time (TST) Averaged Over the Entire Month of the Double Blind Phase.   [ Time Frame: Average of nightly values over the month-long double blind phase ]

2.  Secondary:   Sleep - Mean Subjective SOL, WASO (Wake After Sleep Onset), Sleep Quality and Awakenings, and ISI Over the Month of Double-blind Treatment   [ Time Frame: Averaged over the month of double-blind treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Pain - Mean Change From Baseline in VAS and PGI Pain Ratings Over the Month of Double Blind Treatment.   [ Time Frame: Averaged over the month of double-blind treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Function - Mean Change From Baseline in: RMLBPDQ, HAM-D24 Rating, ISI Function Items, STAI Ratings Averaged for Weeks 1,2, and 4 of Double Blind Treatment. Change From Baseline in Each of the SF-36 Subscales.   [ Time Frame: Averaged for weeks 1,2, and 4 of double blind treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
  1. We obtained only self-reported sleep outcomes.
  2. The period of double-blind treatment was relatively short.
  3. We excluded all subjects who might have required opioid therapy to manage their pain which limits study generalizability.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jenny Bridgers, CRC
Organization: Duke University
phone: 919-684-0752
e-mail: jenny.bridgers@duke.edu


Publications:

Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00365976     History of Changes
Other Study ID Numbers: Pro00011697, ESRC 032
Study First Received: August 16, 2006
Results First Received: March 19, 2013
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board