Clinical trial NCT00551148: A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Insomnia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography
timeFrame: weekly
Secondary outcomes:
measure: 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.
timeFrame: weekly
measure: Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ.
timeFrame: weekly
measure: 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)
timeFrame: weekly
measure: Latency to persistent sleep (LPS) as determined by Polysomnography
timeFrame: weekly
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phenoix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: