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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023745-29 | EudraCT Number |
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This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on night time awakening body sway of melatonin and zolpidem in healthy adult subjects aged of 55 to 64 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Active Comparator | Circadin(R) 2 mg tablet 2 hours at 23:00 |
|
| Zolpidem | Active Comparator | Stilnox (R) 10 mg tablet at 23:00 |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circadin (R) 2 mg | Drug | One 2 mg tablet at 23:00 |
| |
| Stilnox (R) 10 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Body sway | 4 hours post IMP adminstration |
| Measure | Description | Time Frame |
|---|---|---|
| Body Sway | 1.5 hours post administration |
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Inclusion Criteria:
Major Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forenap | Rouffach | France |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
One 10 mg encapsulated tablet at 23:00 |
|
| Placebo | Drug | One tablet or encapsulated tablet at 23:00 |
|
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |