Nonrestorative Sleep Clinical Trial
Official title:
PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of PD 0200390 in Adults With Nonrestorative Sleep
| Verified date | July 2012 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 306 |
| Est. completion date | December 2008 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 64 Years |
| Eligibility |
Inclusion Criteria: - Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening - Self-report wake after sleep onset <45 mins for past 3 mos; self-report latency to sleep onset <20 mins for past 3 mos - PSG (Polysomnography) sleep criteria of wake after sleep onset < 45 mins; Latency to persistent sleep <20 mins. Exclusion Criteria: - MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening - BMI = or > 32 kg/m2 - History or presence of breathing related disorders - PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index > 10/hr; or period limb movement with arousal index > 10/hr. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Pfizer Investigational Site | Etobicoke | Ontario |
| Canada | Pfizer Investigational Site | Kelowna | British Columbia |
| Canada | Pfizer Investigational Site | Kelowna | British Columbia |
| Canada | Pfizer Investigational Site | Kitchener | Ontario |
| Canada | Pfizer Investigational Site | Parry Sound | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Baton Rouge | Louisiana |
| United States | Pfizer Investigational Site | Brighton | Massachusetts |
| United States | Pfizer Investigational Site | Cary | North Carolina |
| United States | Pfizer Investigational Site | Chesterfield | Missouri |
| United States | Pfizer Investigational Site | Chevy Chase | Maryland |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Clarks Summit | Pennsylvania |
| United States | Pfizer Investigational Site | Columbia | South Carolina |
| United States | Pfizer Investigational Site | Crestview Hills | Kentucky |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | DeLand | Florida |
| United States | Pfizer Investigational Site | Gainesville | Georgia |
| United States | Pfizer Investigational Site | Glendale | Arizona |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Irving | Texas |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | N. Dartmouth | Massachusetts |
| United States | Pfizer Investigational Site | Naples | Florida |
| United States | Pfizer Investigational Site | North Haven | Connecticut |
| United States | Pfizer Investigational Site | Oklahoma | Oklahoma |
| United States | Pfizer Investigational Site | Orange City | Florida |
| United States | Pfizer Investigational Site | Orlando | Florida |
| United States | Pfizer Investigational Site | Overland Park | Kansas |
| United States | Pfizer Investigational Site | Pasadena | California |
| United States | Pfizer Investigational Site | Pembroke Pines | Florida |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Salisbury | North Carolina |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | South Miami | Florida |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Tustin | California |
| United States | Pfizer Investigational Site | Uniontown | Pennsylvania |
| United States | Pfizer Investigational Site | Wallingford | Connecticut |
| United States | Pfizer Investigational Site | Warwick | Rhode Island |
| United States | Pfizer Investigational Site | West Seneca | New York |
| United States | Pfizer Investigational Site | West Warwick | Rhode Island |
| United States | Pfizer Investigational Site | Wheat Ridge | Colorado |
| United States | Pfizer Investigational Site | Winston Salem | North Carolina |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire | Weeky | No | |
| Secondary | Total score of the Daily Restorative Sleep Questionnaire | Daily | No | |
| Secondary | Total score of the Multidimensional Assessment of Fatigue (MAF) | Weekly | No | |
| Secondary | Total score of the Sheehan Disability Scale to measure functional impairment | Weekly | No | |
| Secondary | Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute) | Weekly | No | |
| Secondary | Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF) | Weekly | No | |
| Secondary | Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity. | Weekly | No | |
| Secondary | Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician. | Weekly | No | |
| Secondary | Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC). | Weekly | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00705601 -
Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study
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