Trial Outcomes & Findings for Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia (NCT NCT00756002)
NCT ID: NCT00756002
Last Updated: 2010-06-02
Results Overview
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.
COMPLETED
PHASE3
259 participants
Nights 1-2
2010-06-02
Participant Flow
Subjects were enrolled at 19 sites in Europe and Russia from 21 August 2007 to 28 March 2008.
Sleep quality was assessed by postsleep questionnaires during a 21-day placebo run-in. Subjects were enrolled in Ramelteon or Placebo once-daily (QD) treatment group. 488 subjects entered placebo Run-in Period. 229 failed randomization criteria for entry into double-blind study medication phase of the study. 259 were randomized into the study.
Participant milestones
| Measure |
Placebo QD
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
Ramelteon 4 mg QD
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Placebo Run-in
STARTED
|
488
|
0
|
|
Placebo Run-in
COMPLETED
|
259
|
0
|
|
Placebo Run-in
NOT COMPLETED
|
229
|
0
|
|
Double-Blind Treatment Period
STARTED
|
129
|
130
|
|
Double-Blind Treatment Period
COMPLETED
|
114
|
115
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
15
|
15
|
|
Placebo Run-out
STARTED
|
114
|
0
|
|
Placebo Run-out
COMPLETED
|
114
|
0
|
|
Placebo Run-out
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo QD
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
Ramelteon 4 mg QD
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Double-Blind Treatment Period
Lack of Efficacy
|
1
|
1
|
|
Double-Blind Treatment Period
Lost to Follow-up
|
0
|
1
|
|
Double-Blind Treatment Period
Withdrawal by Subject
|
6
|
6
|
|
Double-Blind Treatment Period
Protocol Violation
|
6
|
5
|
|
Double-Blind Treatment Period
Other
|
2
|
2
|
Baseline Characteristics
Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia
Baseline characteristics by cohort
| Measure |
Placebo QD
n=129 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
42.3 years
STANDARD_DEVIATION 12.28 • n=93 Participants
|
41.7 years
STANDARD_DEVIATION 11.85 • n=4 Participants
|
42.0 years
STANDARD_DEVIATION 12.05 • n=27 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
108.0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
151.0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1.0 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1.0 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
128 participants
n=93 Participants
|
129 participants
n=4 Participants
|
257.0 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Nights 1-2Population: The Full Analysis Set (FAS) population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and Last Observation Carried Forward (LOCF) data.
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2).
|
41.7 minutes
Standard Error 2.83
|
67.0 minutes
Standard Error 2.88
|
SECONDARY outcome
Timeframe: Nights 15-16Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16).
|
39.2 minutes
Standard Error 3.04
|
65.3 minutes
Standard Error 3.09
|
SECONDARY outcome
Timeframe: Nights 29-30Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30).
|
37.2 minutes
Standard Error 2.89
|
60.5 minutes
Standard Error 2.95
|
SECONDARY outcome
Timeframe: Nights 1-2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjective sleep latency was collected by subjects answering a post-sleep questionnaire via an interactive voice response system (IVRS) following an overnight Polysomnography in the sleep lab.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=129 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2).
|
61.5 minutes
Standard Error 2.80
|
73.5 minutes
Standard Error 2.84
|
SECONDARY outcome
Timeframe: Nights 15-16Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16).
|
55.8 minutes
Standard Error 3.23
|
72.3 minutes
Standard Error 3.29
|
SECONDARY outcome
Timeframe: Nights 29-30Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30).
|
53.7 minutes
Standard Error 3.53
|
72.3 minutes
Standard Error 3.59
|
SECONDARY outcome
Timeframe: Week 2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=124 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2).
|
52.7 minutes
Standard Error 2.27
|
69.9 minutes
Standard Error 2.31
|
SECONDARY outcome
Timeframe: Week 4Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=125 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4).
|
51.0 minutes
Standard Error 2.18
|
65.7 minutes
Standard Error 2.22
|
SECONDARY outcome
Timeframe: Week 5Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=125 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5).
|
50.4 minutes
Standard Error 2.36
|
67.4 minutes
Standard Error 2.40
|
SECONDARY outcome
Timeframe: Nights 1-2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Total Sleep Time, Per Polysomnography (Nights 1-2).
|
381.1 minutes
Standard Error 3.71
|
356.5 minutes
Standard Error 3.76
|
SECONDARY outcome
Timeframe: Nights 15-16Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Total Sleep Time, Per Polysomnography (Nights 15-16).
|
380.3 minutes
Standard Error 4.09
|
357.0 minutes
Standard Error 4.15
|
SECONDARY outcome
Timeframe: Nights 29-30Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Total Sleep Time, Per Polysomnography (Nights 29-30).
|
386.2 minutes
Standard Error 4.13
|
361.7 minutes
Standard Error 4.19
|
SECONDARY outcome
Timeframe: Nights 1-2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=129 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 1-2).
|
347.0 minutes
Standard Error 3.41
|
330.6 minutes
Standard Error 3.45
|
SECONDARY outcome
Timeframe: Nights 15-16Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 15-16).
|
345.9 minutes
Standard Error 4.57
|
332.6 minutes
Standard Error 4.63
|
SECONDARY outcome
Timeframe: Nights 29 -30Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 29-30).
|
355.3 minutes
Standard Error 5.10
|
335.0 minutes
Standard Error 5.16
|
SECONDARY outcome
Timeframe: Week 2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=124 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 2).
|
357.1 minutes
Standard Error 3.59
|
343.7 minutes
Standard Error 3.65
|
SECONDARY outcome
Timeframe: Week 4Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=125 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 4).
|
366.7 minutes
Standard Error 3.79
|
349.4 minutes
Standard Error 3.84
|
SECONDARY outcome
Timeframe: Week 5Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=125 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 5).
|
366.1 minutes
Standard Error 3.86
|
350.7 minutes
Standard Error 3.90
|
SECONDARY outcome
Timeframe: Nights 1-2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Sleep Efficiency, Per Polysomnography (Nights 1-2).
|
79.5 percentage of time asleep to time in bed
Standard Error 0.77
|
74.3 percentage of time asleep to time in bed
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Nights 15-16Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Sleep Efficiency, Per Polysomnography (Nights 15-16).
|
79.4 percentage of time asleep to time in bed
Standard Error 0.85
|
74.5 percentage of time asleep to time in bed
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Nights 29-30Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The Total Sleep Time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Sleep Efficiency, Per Polysomnography (Nights 29-30).
|
80.5 percentage of time asleep to time in bed
Standard Error 0.86
|
75.6 percentage of time asleep to time in bed
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Nights 1-2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 1-2).
|
4.1 scores on a scale
Standard Error 0.06
|
4.4 scores on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Nights 15-16Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 15-16).
|
3.9 scores on a scale
Standard Error 0.07
|
4.3 scores on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Nights 29-30Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Sleep quality obtained from the Post-Sleep Questionnaireperformed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 29-30).
|
3.7 scores on a scale
Standard Error 0.08
|
4.2 scores on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=124 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 2).
|
3.8 scores on a scale
Standard Error 0.06
|
4.2 scores on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 4Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=125 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 4).
|
3.7 scores on a scale
Standard Error 0.07
|
4.1 scores on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 5Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=125 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 5).
|
3.7 scores on a scale
Standard Error 0.07
|
4.1 scores on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Nights 1-2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Wake Time After Sleep Onset, Per Polysomnography (Nights 1-2).
|
62.2 minutes
Standard Error 2.93
|
61.1 minutes
Standard Error 2.96
|
SECONDARY outcome
Timeframe: Nights 15-16Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Wake Time After Sleep Onset, Per Polysomnography (Nights 15-16).
|
66.1 minutes
Standard Error 3.06
|
62.6 minutes
Standard Error 3.10
|
SECONDARY outcome
Timeframe: Nights 29-30Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Wake Time After Sleep Onset, Per Polysomnography (Nights 29-30).
|
60.3 minutes
Standard Error 3.52
|
62.4 minutes
Standard Error 3.57
|
SECONDARY outcome
Timeframe: Nights 1-2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 1-2).
|
76.3 minutes
Standard Error 3.46
|
82.2 minutes
Standard Error 3.50
|
SECONDARY outcome
Timeframe: Nights 15-16Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 15-16).
|
74.5 minutes
Standard Error 3.94
|
83.8 minutes
Standard Error 4.01
|
SECONDARY outcome
Timeframe: Nights 29-30Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 29-30).
|
63.8 minutes
Standard Error 4.33
|
81.1 minutes
Standard Error 4.40
|
SECONDARY outcome
Timeframe: Week 2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=124 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 2).
|
59.8 minutes
Standard Error 2.62
|
70.8 minutes
Standard Error 2.68
|
SECONDARY outcome
Timeframe: Week 4Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=125 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 4).
|
52.5 minutes
Standard Error 2.83
|
65.8 minutes
Standard Error 2.88
|
SECONDARY outcome
Timeframe: Week 5Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=125 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 5).
|
55.7 minutes
Standard Error 2.91
|
67.7 minutes
Standard Error 2.96
|
SECONDARY outcome
Timeframe: Nights 1-2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2).
|
10.4 awakenings after persistent sleep
Standard Error 0.30
|
9.6 awakenings after persistent sleep
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Nights 15-16Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16).
|
9.7 awakenings after persistent sleep
Standard Error 0.32
|
9.9 awakenings after persistent sleep
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Nights 29-30Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30).
|
9.7 awakenings after persistent sleep
Standard Error 0.33
|
9.8 awakenings after persistent sleep
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Nights 1-2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 1-2).
|
2.8 Number of awakenings per night
Standard Error 0.12
|
2.9 Number of awakenings per night
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Nights 15-16Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 15-16).
|
2.6 Number of awakenings per night
Standard Error 0.13
|
3.0 Number of awakenings per night
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Nights 29-30Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=130 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=128 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 29-30).
|
2.5 Number of awakenings per night
Standard Error 0.12
|
2.8 Number of awakenings per night
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Week 2Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=124 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 2).
|
2.0 scores on a scale
Standard Error 0.08
|
2.2 scores on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 4Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=125 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 4).
|
1.8 scores on a scale
Standard Error 0.08
|
2.2 scores on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 5Population: The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.
The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.
Outcome measures
| Measure |
Ramelteon 4 mg QD
n=127 Participants
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
Placebo QD
n=125 Participants
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 5).
|
2.1 scores on a scale
Standard Error 0.09
|
2.3 scores on a scale
Standard Error 0.09
|
Adverse Events
Placebo QD
Ramelteon 4 mg QD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo QD
n=129 participants at risk
Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
|
Ramelteon 4 mg QD
n=130 participants at risk
Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
2/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Eye disorders
Eye Pain
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Eye disorders
Visual disturbance
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
2/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Gastrointestinal disorders
Dry mouth
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Gastrointestinal disorders
Nausea
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
General disorders
Fatigue
|
0.78%
1/129
No Serious Adverse Events Reported.
|
1.5%
2/130
No Serious Adverse Events Reported.
|
|
Gastrointestinal disorders
Pyrexia
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
General disorders
Inflammation
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
General disorders
Irritability
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
General disorders
Malaise
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
General disorders
Oedema peripheral
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
7/129
No Serious Adverse Events Reported.
|
1.5%
2/130
No Serious Adverse Events Reported.
|
|
Infections and infestations
Bronchitis
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Infections and infestations
Cystitis
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Infections and infestations
Sinusitis
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Infections and infestations
Upper respiratory tract infections
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/129
No Serious Adverse Events Reported.
|
2.3%
3/130
No Serious Adverse Events Reported.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Investigations
Aspartate aminotransferase increased
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Investigations
Blood pressure increased
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Investigations
Lymphocyte count increased
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Investigations
Neutrophil count increased
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Investigations
Transaminases increased
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Metabolism and nutrition disorders
Back pain
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Nervous system disorders
Headache
|
7.8%
10/129
No Serious Adverse Events Reported.
|
6.9%
9/130
No Serious Adverse Events Reported.
|
|
Nervous system disorders
Somnolence
|
0.78%
1/129
No Serious Adverse Events Reported.
|
4.6%
6/130
No Serious Adverse Events Reported.
|
|
Nervous system disorders
Dizziness
|
1.6%
2/129
No Serious Adverse Events Reported.
|
1.5%
2/130
No Serious Adverse Events Reported.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Nervous system disorders
Dysgeusia
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Nervous system disorders
Post-traumatic headache
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Psychiatric disorders
Early morning awakenings
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.77%
1/130
No Serious Adverse Events Reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.78%
1/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/129
No Serious Adverse Events Reported.
|
0.00%
0/130
No Serious Adverse Events Reported.
|
Additional Information
Sr VP, Clinical Science
Takeda Global Research & Development Center, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release; such communications can be embargoed for a period up to 150 days to permit actions necessary to preserve sponsor's intellectual property. Sponsor can request changes to the results communication only for the purpose of removing non study related information that is proprietary and confidential to sponsor. Sponsor can require delay of a results communication until the study has been completed at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER