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

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ClinicalTrials.gov Identifier: NCT00460993
Recruitment Status : Completed
First Posted : April 17, 2007
Results First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Poor Quality Sleep
Intervention: Drug: Lunesta

  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
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

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 
Overall Participants Analyzed 
[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

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

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



Responsible Party: Patricia C Griffiths, Emory University
ClinicalTrials.gov Identifier: NCT00460993     History of Changes
Other Study ID Numbers: 057-2006
LunestaNH ( Other Identifier: Sepracor )
First Submitted: April 16, 2007
First Posted: April 17, 2007
Results First Submitted: November 6, 2013
Results First Posted: July 15, 2014
Last Update Posted: July 15, 2014