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

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Glendale, Arizona, 85306 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Primary Insomnia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00551148
Pfizer
Completed
A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

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Descriptive Information
Brief Title  ICMJE A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
Official Title  ICMJE 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
Brief SummaryThe purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Insomnia
Intervention  ICMJE
  • Drug: 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.
  • Drug: 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.
  • Drug: 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.
  • Drug: 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.
  • Other: Placebo
    oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
Study Arms  ICMJE
  • Experimental: 15 mg
    Intervention: Drug: PD 0200390
  • Experimental: 30 mg
    Intervention: Drug: PD 0200390
  • Experimental: 5 mg
    Intervention: Drug: PD 0200390
  • Experimental: 60 mg
    Intervention: Drug: PD 0200390
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2008)
92
Original Enrollment  ICMJE
 (submitted: October 27, 2007)
80
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion DateJanuary 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00551148
Other Study ID Numbers  ICMJE A4251068
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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