Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Patricia C Griffiths, Emory University
ClinicalTrials.gov Identifier:
NCT00460993
First received: April 16, 2007
Last updated: June 16, 2014
Last verified: June 2014
Results First Received: November 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Poor Quality Sleep
Intervention: Drug: Lunesta

  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
Group 1 Active drug during phase 1, then placebo during phase 2. Lunesta Active drug (eszopiclone) 1 mg for 3 days. If sleep efficiency does not improve in 3 three day, dose increases to 2 mg for the next three days of active drug administration.
Group 2 Placebo during phase 1, then active drug phase 2. One placebo for 6 days

Participant Flow for 2 periods

Period 1:   Phase 1 (6 Days)
    Group 1     Group 2  
STARTED     14     17  
COMPLETED     14     17  
NOT COMPLETED     0     0  

Period 2:   Phase 2 (6 Days)
    Group 1     Group 2  
STARTED     14     17  
COMPLETED     14     17  
NOT COMPLETED     0     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.
71 subjects were in baseline. But only 31 subjects enrolled into the study intervention portion used for analysis.

Reporting Groups
  Description
Group 1 Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration.
Group 2

Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention.

Weeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve.

Total Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Total  
Number of Participants  
[units: participants]
  14     17     31  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     14     17     31  
Age  
[units: years]
Mean ± Standard Deviation
  83.1  ± 8.5     88.9  ± 5.6     86.3  ± 7.7  
Gender  
[units: participants]
     
Female     12     13     25  
Male     2     4     6  
Region of Enrollment  
[units: participants]
     
United States     14     17     31  
Sleep Efficiency  
[units: percent of sleep]
Median ( Full Range )
  56.1  
  ( 28.2 to 74.9 )  
  60.7  
  ( 12.3 to 70.8 )  
  59.1  
  ( 12.3 to 74.9 )  



  Outcome Measures

1.  Primary:   Sleep Efficiency   [ Time Frame: 6 days ]


  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
Low power to detect statistically significant effects of the interventions on outcomes; Inability to examine predictors of responsiveness because of the small sample size and the large number of predictors of response.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Patricia C. Griffiths
Organization: Atlanta VA Medical Center
phone: 404-321-6111 ext 7138
e-mail: Patricia.Griffiths@va.gov


No publications provided


Responsible Party: Patricia C Griffiths, Emory University
ClinicalTrials.gov Identifier: NCT00460993     History of Changes
Other Study ID Numbers: 057-2006, LunestaNH
Study First Received: April 16, 2007
Results First Received: November 6, 2013
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board