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This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group exploratory study in patients with insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TS-142 2.5 mg | Experimental | Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime |
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| TS-142 5 mg | Experimental | Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime |
|
| TS-142 10 mg | Experimental | Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime |
|
| Placebo | Experimental | Period in which participants received single placebo prior to bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-142 | Drug | Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet) |
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| Measure | Description | Time Frame |
|---|---|---|
| LS mean difference from placebo; Change between baseline and end of the study of sSL | sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary | Baseline and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| LS mean difference from placebo; Change between baseline and end of the study of sTST | sTST is defined as the total amount of time spent asleep before getting-out from his/her bed for the day as recorded in a sleep diary | Baseline and Week 2 |
| LS mean difference from placebo; Change between baseline and end of the study of sWASO |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taisho Director | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taisho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
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| ID | Term |
|---|---|
| C000723815 | TS-142 |
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sWASO is defined as the total amount of time spent awake after falling asleep and before getting-out from bed for the day as recorded in a sleep diary. |
| Baseline and Week 2 |