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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1115-2062 | Registry Identifier | WHO |
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The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia
Complaints of sleep disorder are increasing with today's aging society and changing lifestyle. Sleep disorders not only impact one's activities of daily living, but also impede one's social life, leading to reduced productivity and sometimes accidents through carelessness.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramelteon QD and Placebo QD (25 possible combinations total) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon and Placebo (25 possible combinations total) | Drug | Randomized sequence over two consecutive nights for a total of five treatment periods to include the following: Ramelteon 4 mg, tablets, orally over two nights Ramelteon 8 mg, tablets, orally over two nights Ramelteon 16 mg, tablets, orally over two nights Ramelteon 32 mg, tablets, orally over two nights Ramelteon placebo-matching tablets, orally over two nights |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Latency to Persistent Sleep | Mean of Nights 1 and 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Total Sleep Time | Mean of Nights 1 and 2. | |
| Sleep Efficiency | Mean of Nights 1 and 2 | |
| Awake Time after Persistent Sleep |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
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| Label | URL |
|---|---|
| Rozerem Package Insert. | View source |
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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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| Mean of Nights 1 and 2. |
| Percent of Total Sleep Time in NREM sleep Stage 1 | Mean of Nights 1 and 2. |
| Percent of Total Sleep Time in NREM sleep Stage 2 | Mean of Nights 1 and 2. |
| Percent of Total Sleep Time in NREM sleep Stage 3/4 | Mean of Nights 1 and 2. |
| Percent of Total Sleep Time in REM sleep Stage | Mean of Nights 1 and 2. |
| Latency to REM sleep stage | Mean of Nights 1 and 2. |
| Subjective Sleep Latency | Mean of Nights 1 and 2. |
| Subjective Total Sleep Time | Mean of Nights 1 and 2. |
| Subjective Sleep Quality | Mean of Nights 1 and 2. |
| D001523 |
| Mental Disorders |