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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132358 | Registry Identifier | JapicCTI | |
| JapicCTI-R150751 | Registry Identifier | JapicCTI |
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The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.
This is a drug use surveillance planned to examine the safety and efficacy of ramelteon tablets when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia (planned sample size, 3000)
The usual adult dosage is 8 mg of ramelteon administered orally once daily at bedtime.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramelteon 8 mg administered orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon | Drug | Ramelteon 8 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE 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. | Baseline up to 6 weeks |
| Number of Participants Reporting One or More Serious Adverse Drug Reactions | Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Status: Sleep Onset Latency | 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. | Baseline and Week 4 |
| Sleep Status: Total Sleep Time |
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Inclusion Criteria:
1. Sleep-onset difficulty associated with insomnia
Exclusion Criteria:
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Insomnia
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| Name | Affiliation | Role |
|---|---|---|
| Postmarketing Group Manager | Takeda | Study Chair |
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Participants with a historical diagnosis of insomnia who were facing difficulty in falling asleep in daily clinical practice were enrolled in single treatment group to receive ramelteon 8 milligram (mg).
Participants took part in the study at 557 investigative site in Japan from 30 July 2010 to 30 April 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramelteon | Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set was defined as participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramelteon | Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting One or More Adverse Drug Reactions | Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE 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. | Safety analysis set was defined as participants who were enrolled and completed the study. | Posted | Number | participants | Baseline up to 6 weeks |
|
Baseline up to 6 weeks
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 collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ramelteon | Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA (16.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
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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.
| Baseline and Week 4 |
| Sleep Status: Number of Awakenings | 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. | Baseline and Week 4 |
| Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4 | PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. 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 for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition. | Week 4 |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Type of Sleep Disorder (Major Symptoms) | Sleep disorder was categorized on the basis of symptoms found in participants. | Number | participants |
|
| Degree of Sleep Disorder | Degree of sleep disorder of participants were categorized on the basis of the judgement of the investigator as mild, moderate and severe. | Number | participants |
|
| Duration of Insomnia | Mean | Standard Deviation | years |
|
| Duration of Insomnia | Number | participants |
|
| Presence of Complications | Number | participants |
|
| Breakdown of complications | Participants could be counted in more than 1 category (including duplicates). | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | SAS was defined as participants who were enrolled and completed the study. | Posted | Number | participants | Baseline up to 6 weeks |
|
|
|
| Secondary | Sleep Status: Sleep Onset Latency | 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 efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | Posted | Mean | Standard Deviation | minutes | Baseline and Week 4 |
|
|
|
| Secondary | Sleep Status: Total Sleep Time | Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode. | The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | Posted | Mean | Standard Deviation | hours | Baseline and Week 4 |
|
|
|
| Secondary | Sleep Status: Number of Awakenings | 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 efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | Posted | Mean | Standard Deviation | number of awakenings | Baseline and Week 4 |
|
|
|
| Secondary | Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4 | PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. 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 for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition. | The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | Posted | Number | percentage of participants | Week 4 |
|
|
|
| 1 |
| 3,223 |
| 37 |
| 3,223 |
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.
| D001523 |
| Mental Disorders |
| Title | Measurements |
|---|---|
|
| Morning awakening |
|
| Morning tiredness |
|
| Daytime sleepiness |
|
| Daytime physical condition/function |
|