- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02153086
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 -
August 17, 2016 updated by: Takeda
Rozerem 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Associated With Sleep-onset Difficulty > - Transitional Survey From the Preceding Drug-use Survey -
The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.
Study Overview
Detailed Description
This survey was designed to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.The usual dosage for adults is 8 mg of ramelteon administered orally once daily at bedtime.
Study Type
Observational
Enrollment (Actual)
236
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Osaka, Japan
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Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Insomnia
Description
Inclusion Criteria:
-Participants with difficulty falling asleep associated with insomnia who have completed a 4-week follow-up in the preceding drug use surveillance and are able to receive continuous administration of Rozerem Tablets
Exclusion Criteria:
- Participants with contraindications to Rozerem Tablets.
- Participants with previous history of hypersensitivity to ingredients in Rozerem Tablets.
- Participants with severe liver dysfunction.
- Participants taking fluvoxamine maleate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Ramelteon 8 mg Tablets
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Ramelteon tablets 8 mg
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Reporting One or More Adverse Drug Reactions
Time Frame: Baseline up to 12 months
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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.
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Baseline up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Status: Sleep Onset Latency
Time Frame: Baseline, Week 4 and Month 12
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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).
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Baseline, Week 4 and Month 12
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Sleep Status: Total Sleep Time
Time Frame: Baseline, Week 4 and Month 12
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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).
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Baseline, Week 4 and Month 12
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Sleep Status: Number of Awakenings
Time Frame: Baseline, Week 4 and Month 12
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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).
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Baseline, Week 4 and Month 12
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Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset
Time Frame: At Week 4, 52, and final assessment (up to 12 months)
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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).
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At Week 4, 52, and final assessment (up to 12 months)
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Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration
Time Frame: At Week 4, 52, and final assessment (up to 12 months)
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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).
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At Week 4, 52, and final assessment (up to 12 months)
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Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality
Time Frame: At Week 4, 52, and final assessment (up to 12 months)
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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).
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At Week 4, 52, and final assessment (up to 12 months)
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Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening
Time Frame: At Week 4, 52, and final assessment (up to 12 months)
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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).
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At Week 4, 52, and final assessment (up to 12 months)
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Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning
Time Frame: At Week 4, 52, and final assessment (up to 12 months)
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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).
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At Week 4, 52, and final assessment (up to 12 months)
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Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence
Time Frame: At Week 4, 52, and final assessment (up to 12 months)
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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).
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At Week 4, 52, and final assessment (up to 12 months)
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Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function
Time Frame: At Week 4, 52, and final assessment (up to 12 months)
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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).
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At Week 4, 52, and final assessment (up to 12 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 29, 2014
First Submitted That Met QC Criteria
May 29, 2014
First Posted (Estimate)
June 2, 2014
Study Record Updates
Last Update Posted (Estimate)
October 13, 2016
Last Update Submitted That Met QC Criteria
August 17, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 293-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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