Status:
COMPLETED
A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
Lead Sponsor:
Pfizer
Conditions:
Nonrestorative Sleep
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00655369
Start Date
April 1 2008
End Date
December 1 2008
Last Update
July 25 2012
Active Locations (59)
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1
Pfizer Investigational Site
Glendale, Arizona, United States, 85306
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85306
3
Pfizer Investigational Site
Tucson, Arizona, United States, 85712
4
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205