A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
NCT ID: NCT00551148
Last Updated: 2012-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2007-10-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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15 mg
PD 0200390
oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
30 mg
PD 0200390
oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
5 mg
PD 0200390
oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
60 mg
PD 0200390
oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
Placebo
Placebo
oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
Interventions
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PD 0200390
oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
PD 0200390
oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
PD 0200390
oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
PD 0200390
oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
Placebo
oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
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
18 Years
64 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4251068
Identifier Type: -
Identifier Source: org_study_id