A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

Completed · Phase 2 · Has a placebo group

Conditions studied: Insomnia

In brief

To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.

Key facts

Study ID

NCT00569972

Run by

Pfizer

People needed

682

Starts

2007-10-01

Expected to finish

2009-01-01

Last updated by the study team

2012-07-25

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 3 month history of primary insomnia;
• 18 to 64 years
• For the last 3 months-regularly awake unrefreshed and unrestored
• Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)

You may not qualify if…

• Any history of an Axis 1 psychiatric diagnosis;
• History or presence of any breathing related sleep disorder;
• History or presence of any medical or neurological condition that could interfere with sleep
• Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week

Where it is running

• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Scottsdale, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Encino, California, United States
• Pfizer Investigational Site — Garden Grove, California, United States
• Pfizer Investigational Site — Los Alamitos, California, United States
• Pfizer Investigational Site — Newport Beach, California, United States
• Pfizer Investigational Site — Redlands, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Sherman Oaks, California, United States
• Pfizer Investigational Site — Colorado Springs, Colorado, United States
• Pfizer Investigational Site — Brooksville, Florida, United States
• Pfizer Investigational Site — DeLand, Florida, United States
• Pfizer Investigational Site — Hallandale, Florida, United States
• Pfizer Investigational Site — Hallandale, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Jupiter, Florida, United States
• Pfizer Investigational Site — Maitland, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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