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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:
Sunovion
Information provided by (Responsible Party):
Patricia C Griffiths, Emory University

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
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description 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. Placebo during phase 1, then active drug phase 2. One placebo for 6 days
Period Title: Phase 1 (6 Days)
Started 14 17
Completed 14 17
Not Completed 0 0
Period Title: Phase 2 (6 Days)
Started 14 17
Completed 14 17
Not Completed 0 0
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 14 17 31
Hide Baseline Analysis Population Description
71 subjects were in baseline. But only 31 subjects enrolled into the study intervention portion used for analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
14
 100.0%
17
 100.0%
31
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 17 participants 31 participants
83.1  (8.5) 88.9  (5.6) 86.3  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
Female
12
  85.7%
13
  76.5%
25
  80.6%
Male
2
  14.3%
4
  23.5%
6
  19.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 17 participants 31 participants
14 17 31
Sleep Efficiency  
Median (Full Range)
Unit of measure:  Percent of sleep
Number Analyzed 14 participants 17 participants 31 participants
56.1
(28.2 to 74.9)
60.7
(12.3 to 70.8)
59.1
(12.3 to 74.9)
1.Primary Outcome
Title Sleep Efficiency
Hide Description Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by polysomnography in a subgroup of subjects), holding constant time in bed and recording time
Time Frame 6 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Active drug given in phase 1, then Placebo pill in phase 2. Lunesta Active drug (eszopiclone) 1 mg during three days of active drug. If sleep efficiency does not improve doses increases to 2 mg for the next three days of active drug administration.
Placebo pill in phase 1, then Active drug given in phase 2. One placebo pill for 6 days
Overall Number of Participants Analyzed 14 17
Median (Full Range)
Unit of Measure: percentage of sleep
70.0
(18.1 to 85.2)
65.8
(16.0 to 83.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description Active drug given in phase 1, then placebo pill given in phase 2. Placebo pill given in phase 1, then active drug give in phase 2. One placebo pill for 6 days.
All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/17 (0.00%) 
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.
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
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