Trial Outcomes & Findings for Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients (NCT NCT00460993)
NCT ID: NCT00460993
Last Updated: 2014-07-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
6 days
Results posted on
2014-07-15
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Phase 1 (6 Days)
STARTED
|
14
|
17
|
|
Phase 1 (6 Days)
COMPLETED
|
14
|
17
|
|
Phase 1 (6 Days)
NOT COMPLETED
|
0
|
0
|
|
Phase 2 (6 Days)
STARTED
|
14
|
17
|
|
Phase 2 (6 Days)
COMPLETED
|
14
|
17
|
|
Phase 2 (6 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients
Baseline characteristics by cohort
| Measure |
Group 1
n=14 Participants
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
n=17 Participants
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
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Age, Continuous
|
83.1 years
STANDARD_DEVIATION 8.5 • n=93 Participants
|
88.9 years
STANDARD_DEVIATION 5.6 • n=4 Participants
|
86.3 years
STANDARD_DEVIATION 7.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
17 participants
n=4 Participants
|
31 participants
n=27 Participants
|
|
Sleep Efficiency
|
56.1 percent of sleep
n=93 Participants
|
60.7 percent of sleep
n=4 Participants
|
59.1 percent of sleep
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 daysPercentage 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
Outcome measures
| Measure |
Group 1
n=14 Participants
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.
|
Group 2
n=17 Participants
Placebo pill in phase 1, then Active drug given in phase 2. One placebo pill for 6 days
|
|---|---|---|
|
Sleep Efficiency
|
70.0 percentage of sleep
Interval 18.1 to 85.2
|
65.8 percentage of sleep
Interval 16.0 to 83.5
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place