A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Insomnia

In brief

The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.

Key facts

Study ID

NCT00551148

Run by

Pfizer

People needed

92

Starts

2007-10-01

Expected to finish

2008-01-01

Last updated by the study team

2012-07-25

Who can join

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

You may qualify if…

• 3 month history of Primary Insomnia (DSM-IV criteria)
• Self report sleep criteria for at least 3 nights per week in past month;
• sWASO (subjective wake after sleep onset) equal or greater than 60 mins
• sLSO (subjective latency to sleep onset) equal or greater than 45 minutes
• TST less than or equal to 6.5 hrs
• Maintain normal daytime-awake, nighttime-sleep schedule
• PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights
• TST between 3 to 7 hrs on 2 PSG screening nights
• Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights

You may not qualify if…

• Comorbid psychiatric disease or disorders
• History or presence of breathing-related disorders
• Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening
• History or presence of medical or neurological condition interfering with sleep
• Current use of know psychotropic effect medications
• Excessive caffeine use
• Use of alcohol as a sleep aid or more than 2 standard drinks/day

Where it is running

• Pfizer Investigational Site — Glendale, Arizona, United States
• Pfizer Investigational Site — Phenoix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Naples, 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 — Overland Park, Kansas, United States
• Pfizer Investigational Site — Crestview Hills, Kentucky, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Cary, North Carolina, United States
• Pfizer Investigational Site — Raleigh, North Carolina, United States
• Pfizer Investigational Site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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