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In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg | Experimental |
| |
| 25 mg | Experimental |
| |
| 35 mg | Experimental |
| |
| 5 mg | Experimental |
| |
| 50 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0200390 | Drug | oral 15 mg daily dose, 3 capsules per dose during a six week treatment period. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly) | Weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire | Weeky | |
| Total score of the Daily Restorative Sleep Questionnaire | Daily | |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25024650 | Derived | Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PD 0200390 |
| Drug |
oral 25 mg daily dose, 3 capsules per dose during a six week treatment period. |
|
| PD 0200390 | Drug | oral 35 mg daily dose, 3 capsules per dose during a six week treatment period. |
|
| PD 0200390 | Drug | oral 5 mg daily dose, 3 capsules per dose during a six week treatment period. |
|
| PD 0200390 | Drug | oral 50 mg daily dose, 3 capsules per dose during a six week treatment period. |
|
| Placebo | Drug | oral placebo daily dose, 3 capsules per dose during a six week treatment period. |
|
| Total score of the Multidimensional Assessment of Fatigue (MAF) |
| Weekly |
| Total score of the Sheehan Disability Scale to measure functional impairment | Weekly |
| Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute) | Weekly |
| Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF) | Weekly |
| Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity. | Weekly |
| Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician. | Weekly |
| Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC). | Weekly |
| Phoenix |
| Arizona |
| 85306 |
| United States |
| Pfizer Investigational Site | Tucson | Arizona | 85712 | United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90048 | United States |
| Pfizer Investigational Site | Pasadena | California | 91106 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | San Francisco | California | 94105 | United States |
| Pfizer Investigational Site | Tustin | California | 92780 | United States |
| Pfizer Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| Pfizer Investigational Site | North Haven | Connecticut | 06473 | United States |
| Pfizer Investigational Site | Wallingford | Connecticut | 06492 | United States |
| Pfizer Investigational Site | DeLand | Florida | 32720 | United States |
| Pfizer Investigational Site | Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Naples | Florida | 34110 | United States |
| Pfizer Investigational Site | Orange City | Florida | 32763 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33026 | 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 | Gainesville | Georgia | 30501 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60634 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46260 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Crestview Hills | Kentucky | 41017 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40504 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40513 | United States |
| Pfizer Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| Pfizer Investigational Site | Chevy Chase | Maryland | 20815 | United States |
| Pfizer Investigational Site | Brighton | Massachusetts | 02135 | United States |
| Pfizer Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| Pfizer Investigational Site | Chesterfield | Missouri | 63017 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63108 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89104 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89146 | United States |
| Pfizer Investigational Site | West Seneca | New York | 14224 | United States |
| Pfizer Investigational Site | Cary | North Carolina | 27511 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27607-6520 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Pfizer Investigational Site | Salisbury | North Carolina | 28144 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45227 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Pfizer Investigational Site | Clarks Summit | Pennsylvania | 18411 | United States |
| Pfizer Investigational Site | Uniontown | Pennsylvania | 15401 | United States |
| Pfizer Investigational Site | Warwick | Rhode Island | 02886 | United States |
| Pfizer Investigational Site | West Warwick | Rhode Island | 02893 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29201 | United States |
| Pfizer Investigational Site | Austin | Texas | 78756 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Irving | Texas | 75039 | United States |
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 3G8 | Canada |
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 4R9 | Canada |
| Pfizer Investigational Site | Etobicoke | Ontario | M9W 6V1 | Canada |
| Pfizer Investigational Site | Kitchener | Ontario | N2G 1G1 | Canada |
| Pfizer Investigational Site | Parry Sound | Ontario | P2A 3A4 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M4P 1P2 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M6J 3S3 | Canada |
| ID | Term |
|---|---|
| C547571 | (1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid |
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