Clinical trial NCT00655369: A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonrestorative Sleep
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-09
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Weekly
Secondary outcomes:
measure: Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire
timeFrame: Weeky
measure: Total score of the Daily Restorative Sleep Questionnaire
timeFrame: Daily
measure: Total score of the Multidimensional Assessment of Fatigue (MAF)
timeFrame: Weekly
measure: Total score of the Sheehan Disability Scale to measure functional impairment
timeFrame: Weekly
measure: Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute)
timeFrame: Weekly
measure: Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF)
timeFrame: Weekly
measure: Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity.
timeFrame: Weekly
measure: Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician.
timeFrame: Weekly
measure: Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC).
timeFrame: Weekly
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Wheat Ridge
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: North Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Wallingford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Chevy Chase
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Brighton
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: N. Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: West Seneca
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Clarks Summit
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: West Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Irving
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Etobicoke
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Parry Sound
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.