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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
306
oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.
oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.
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)
Time frame: Weekly
Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire
Time frame: Weeky
Total score of the Daily Restorative Sleep Questionnaire
Time frame: Daily
Total score of the Multidimensional Assessment of Fatigue (MAF)
Time frame: Weekly
Total score of the Sheehan Disability Scale to measure functional impairment
Time frame: Weekly
Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute)
Time frame: Weekly
Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF)
Time frame: Weekly
Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity.
Time frame: Weekly
Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician.
Time frame: Weekly
Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC).
Time frame: Weekly
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oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.
oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
oral placebo daily dose, 3 capsules per dose during a six week treatment period.
Pfizer Investigational Site
Glendale, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
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Los Angeles, California, United States
Pfizer Investigational Site
Pasadena, California, United States
Pfizer Investigational Site
San Diego, California, United States
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San Francisco, California, United States
Pfizer Investigational Site
Tustin, California, United States
Pfizer Investigational Site
Wheat Ridge, Colorado, United States
...and 49 more locations