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The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg | Experimental |
| |
| 30 mg | Experimental |
| |
| 5 mg | Experimental |
| |
| 60 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0200390 | Drug | oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography | weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective assessments of wake after sleep onset (sWASO), latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO), total sleep time (TST), and sleep quality via questionnaire. | weekly | |
| Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ. |
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Inclusion Criteria:
3 month history of Primary Insomnia (DSM-IV criteria)
Self report sleep criteria for at least 3 nights per week in past month;
sWASO (subjective wake after sleep onset) equal or greater than 60 mins
sLSO (subjective latency to sleep onset) equal or greater than 45 minutes
TST less than or equal to 6.5 hrs
Maintain normal daytime-awake, nighttime-sleep schedule
PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights
TST between 3 to 7 hrs on 2 PSG screening nights
Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights
Exclusion Criteria:
Comorbid psychiatric disease or disorders
History or presence of breathing-related disorders
Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening
History or presence of medical or neurological condition interfering with sleep
Current use of know psychotropic effect medications
Excessive caffeine use
Use of alcohol as a sleep aid or more than 2 standard drinks/day
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Glendale | Arizona | 85306 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PD 0200390 | Drug | oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks. |
|
| PD 0200390 | Drug | oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks. |
|
| PD 0200390 | Drug | oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks. |
|
| Placebo | Other | oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks. |
|
| weekly |
| PSG efficacy assessments including number of awakenings after sleep onset (NAASO), number of arousals, total sleep time (TST), sleep efficiency (SE), total wake time (TWT) | weekly |
| Latency to persistent sleep (LPS) as determined by Polysomnography | weekly |
| Phenoix |
| Arizona |
| 85006 |
| United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85006 | United States |
| Pfizer Investigational Site | Tucson | Arizona | 85712 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Naples | Florida | 34110 | United States |
| Pfizer Investigational Site | South Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30328 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30342 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Crestview Hills | Kentucky | 41017 | United States |
| Pfizer Investigational Site | New York | New York | 10019 | United States |
| Pfizer Investigational Site | Cary | North Carolina | 27511 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45227 | United States |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C547571 | (1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid |
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