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This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PD 0200390, 5 mg | Experimental |
| |
| PD 0200390, 15 mg | Experimental |
| |
| PD 0200390, 30 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wake After Sleep Onset (WASO) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ) | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 | |
| Latency to persistent sleep (LPS) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | 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 |
|---|---|
| C547571 | (1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid |
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| PD 0200390 | Drug | Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab. |
|
| PD 0200390 | Drug | Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab. |
|
| PD 0200390 | Drug | Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab. |
|
| Latency to REM Sleep as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Sleep efficiency (SE) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Number of awakenings after sleep onset (NAASO) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Total wake time (TWT) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 |
| Number of arousals as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Total sleep time (TST) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Next day performance sa determined by Digit Symbol Substitution Test (DSST) | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 |
| Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ) | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 |
| Wake time during sleep (WTDS) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Wake time after sleep (WTAS) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D) | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 |
| D001523 |
| Mental Disorders |