A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
PD 0200390 Dose-ranging Trial: A Randomized, Double-blind, Placebo-controlled, 5-way Crossover, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
1 other identifier
interventional
92
1 country
16
Brief Summary
The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2007
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 27, 2007
CompletedFirst Posted
Study publicly available on registry
October 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedJuly 25, 2012
July 1, 2012
3 months
October 27, 2007
July 17, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography
weekly
Secondary Outcomes (4)
Subjective assessments of wake after sleep onset (sWASO), latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO), total sleep time (TST), and sleep quality via questionnaire.
weekly
Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ.
weekly
PSG efficacy assessments including number of awakenings after sleep onset (NAASO), number of arousals, total sleep time (TST), sleep efficiency (SE), total wake time (TWT)
weekly
Latency to persistent sleep (LPS) as determined by Polysomnography
weekly
Study Arms (5)
15 mg
EXPERIMENTAL30 mg
EXPERIMENTAL5 mg
EXPERIMENTAL60 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
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
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (16)
Pfizer Investigational Site
Glendale, Arizona, 85306, United States
Pfizer Investigational Site
Phenoix, Arizona, 85006, United States
Pfizer Investigational Site
Phoenix, Arizona, 85006, United States
Pfizer Investigational Site
Tucson, Arizona, 85712, United States
Pfizer Investigational Site
San Diego, California, 92103, United States
Pfizer Investigational Site
Miami, Florida, 33143, United States
Pfizer Investigational Site
Naples, Florida, 34110, United States
Pfizer Investigational Site
South Miami, Florida, 33143, United States
Pfizer Investigational Site
Atlanta, Georgia, 30328, United States
Pfizer Investigational Site
Atlanta, Georgia, 30342, United States
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017, United States
Pfizer Investigational Site
New York, New York, 10019, United States
Pfizer Investigational Site
Cary, North Carolina, 27511, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27612, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45227, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2007
First Posted
October 30, 2007
Study Start
October 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
July 25, 2012
Record last verified: 2012-07