ClinicalTrials.gov
ClinicalTrials.gov Menu

Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> − Transitional Survey From the Preceding Drug-use Survey −

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02153086
Recruitment Status : Completed
First Posted : June 2, 2014
Results First Posted : October 13, 2016
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Insomnia
Intervention Drug: Ramelteon
Enrollment 236
Recruitment Details Participants took part in the study at 2 investigative sites in Japan from 01 March 2011 to 30 June 2014.
Pre-assignment Details Participants with a historical diagnosis of insomnia which was associated with difficulty in falling asleep in daily clinical practice were enrolled in a single treatment group to receive ramelteon 8 milligram (mg).
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Period Title: Overall Study
Started 236
Completed 232
Not Completed 4
Reason Not Completed
Not enrolled >=28 days and <=56 days             2
Other             2
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Baseline Participants 232
Hide Baseline Analysis Population Description
The safety analysis set was defined as all participants who were enrolled and completed the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 232 participants
65.1  (18.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants
Female
139
  59.9%
Male
93
  40.1%
Type of sleep disorders (Major symptoms)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants
Difficulty falling asleep 127
Difficulty getting sound sleep 16
Difficulty staying asleep 44
Early morning awakening 2
Unknown 43
[1]
Measure Description: Type of sleep disorders were classified on the basis of major symptoms as difficulty falling asleep, difficulty getting sound sleep, difficulty staying asleep, early morning awakening, and unknown.
Degree of sleep disorders   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants
Mild 72
Moderate 130
Severe 30
[1]
Measure Description: Degree of sleep disorders were categorized on the basis of severity, as mild, moderate or severe.
Duration of insomnia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants
Less than (<) 1 year 102
Greater than equal to (>=) 1 year to <3 years 15
>=3 to <5 years 14
>=5 years 11
Unknown 90
Presence of complications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants
Had Complications 193
Had No Complications 39
Breakdown of complications   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants
Hypertension 86
Dyslipidaemia 57
Mental disease 32
Allergic disease 23
Diabetes mellitus 22
Heart or cerebrovascular disease 22
Renal and urinary disorders 17
[1]
Measure Description: Complications were categorized as hypertension, dyslipidaemia, mental disease, allergic disease, diabetes mellitus, heart or cerebrovascular disease, and renal and urinary disorders. Participants may be represented in more than 1 category.
1.Primary Outcome
Title Number of Participants Reporting One or More Adverse Drug Reactions
Hide Description Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Time Frame Baseline up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all participants who were enrolled and completed the study.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 232
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Sleep Status: Sleep Onset Latency
Hide Description Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).
Time Frame Baseline, Week 4 and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 207
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline (n=143) 98.7  (73.3)
At Week 4 (n=109) 48.3  (57.6)
At Final Assessment (n=127) 38.9  (39.4)
3.Secondary Outcome
Title Sleep Status: Total Sleep Time
Hide Description Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).
Time Frame Baseline, Week 4 and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 207
Mean (Standard Deviation)
Unit of Measure: hours
Baseline (n=137) 6.74  (2.11)
At Week 4 (n=102) 7.51  (1.64)
At Final Assessment (n=120) 7.46  (1.72)
4.Secondary Outcome
Title Sleep Status: Number of Awakenings
Hide Description Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).
Time Frame Baseline, Week 4 and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 207
Mean (Standard Deviation)
Unit of Measure: number of awakenings
Baseline (n=150) 2.3  (1.5)
At Week 4 (n=115) 1.2  (1.2)
At Final Assessment (n=136) 1.1  (1.1)
5.Secondary Outcome
Title Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset
Hide Description Sleep onset was defined as the transition from wakefulness into sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Time Frame At Week 4, 52, and final assessment (up to 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 207
Measure Type: Number
Unit of Measure: percentage of participants
At Week 4 (n=207) 80.2
At Week 52 (n=88) 93.2
At Final Assessment (n=207) 85.5
6.Secondary Outcome
Title Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration
Hide Description Sleep duration was defined as the total amount of sleep obtained. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Time Frame At Week 4, 52, and final assessment (up to 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 207
Measure Type: Number
Unit of Measure: percentage of participants
At Week 4 (n=207) 77.8
At Week 52 (n=88) 93.2
At Final Assessment (n=207) 84.0
7.Secondary Outcome
Title Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality
Hide Description Sleep quality was defined as participants satisfaction of the sleep experience, integrating aspects of sleep initiation, sleep maintenance, sleep quantity, and refreshment upon awakening. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Time Frame At Week 4, 52, and final assessment (up to 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 207
Measure Type: Number
Unit of Measure: percentage of participants
At Week 4 (n=207) 80.2
At Week 52 (n=88) 93.2
At Final Assessment (n=207) 86.0
8.Secondary Outcome
Title Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening
Hide Description Morning awakening was defined as the return to the awaked state from any non-rapid eye movement (NREM) to rapid eye movement (REM) sleep stages in the morning. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Time Frame At Week 4, 52, and final assessment (up to 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 207
Measure Type: Number
Unit of Measure: percentage of participants
At Week 4 (n=207) 67.6
At Week 52 (n=88) 87.5
At Final Assessment (n=207) 77.8
9.Secondary Outcome
Title Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning
Hide Description Remaining tiredness in the morning was defined as an experience of fatigue after complete or adequate sleep duration. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Time Frame At Week 4, 52, and final assessment (up to 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 207
Measure Type: Number
Unit of Measure: percentage of participants
At Week 4 (n=207) 72.5
At Week 52 (n=88) 81.8
At Final Assessment (n=207) 77.3
10.Secondary Outcome
Title Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence
Hide Description Daytime somnolence was defined as excessive daytime sleepiness (EDS), characterized by general lack of energy, even after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Time Frame At Week 4, 52, and final assessment (up to 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 207
Measure Type: Number
Unit of Measure: percentage of participants
At Week 4 (n=207) 65.2
At Week 52 (n=88) 81.8
At Final Assessment (n=207) 76.8
11.Secondary Outcome
Title Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function
Hide Description Daytime physical condition/function was defined as general condition of participant throughout the day after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Time Frame At Week 4, 52, and final assessment (up to 12 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description:
Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
Overall Number of Participants Analyzed 207
Measure Type: Number
Unit of Measure: percentage of participants
At Week 4 (n=207) 70.5
At Week 52 (n=88) 84.1
At Final Assessment (n=207) 77.3
Time Frame Baseline up to 12 months
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were analyzed in this study.
 
Arm/Group Title Ramelteon 8 mg
Hide Arm/Group Description Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
All-Cause Mortality
Ramelteon 8 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ramelteon 8 mg
Affected / at Risk (%)
Total   0/232 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ramelteon 8 mg
Affected / at Risk (%)
Total   0/232 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02153086     History of Changes
Other Study ID Numbers: 293-011
First Submitted: May 29, 2014
First Posted: June 2, 2014
Results First Submitted: August 17, 2016
Results First Posted: October 13, 2016
Last Update Posted: October 13, 2016