A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonrestorative Sleep

In brief

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.

Key facts

Study ID

NCT00655369

Run by

Pfizer

People needed

306

Starts

2008-04-01

Expected to finish

2008-12-01

Last updated by the study team

2012-07-25

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Pasadena, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — Tustin, California, United States
• Pfizer Investigational Site — Wheat Ridge, Colorado, United States
• Pfizer Investigational Site — North Haven, Connecticut, United States
• Pfizer Investigational Site — Wallingford, Connecticut, United States
• Pfizer Investigational Site — DeLand, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Naples, Florida, United States
• Pfizer Investigational Site — Orange City, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Pembroke Pines, Florida, United States
• Pfizer Investigational Site — South Miami, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Gainesville, Georgia, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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