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A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia

Primary Purpose

Insomnia

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
PD 0200390
PD 0200390
PD 0200390
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 3 month history of primary insomnia
  • Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)

Exclusion Criteria:

  • Any history of psychiatric diagnosis
  • History or presence of any breathing related sleep disorder
  • History or presence of any medical or neurological condition that could interfere with sleep
  • Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    PD 0200390, 5 mg

    PD 0200390, 15 mg

    PD 0200390, 30 mg

    Arm Description

    Outcomes

    Primary Outcome Measures

    Wake After Sleep Onset (WASO) as determined by PSG assessment

    Secondary Outcome Measures

    Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ)
    Latency to persistent sleep (LPS) as determined by PSG assessment
    Latency to REM Sleep as determined by PSG assessment
    Sleep efficiency (SE) as determined by PSG assessment
    Number of awakenings after sleep onset (NAASO) as determined by PSG assessment
    Total wake time (TWT) as determined by PSG assessment
    Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness
    Number of arousals as determined by PSG assessment
    Total sleep time (TST) as determined by PSG assessment
    Next day performance sa determined by Digit Symbol Substitution Test (DSST)
    Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ)
    Wake time during sleep (WTDS) as determined by PSG assessment
    Wake time after sleep (WTAS) as determined by PSG assessment
    Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment
    Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D)

    Full Information

    First Posted
    September 5, 2008
    Last Updated
    February 11, 2009
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00748592
    Brief Title
    A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
    Official Title
    PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    June 2009 (Anticipated)
    Study Completion Date
    June 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia
    Keywords
    Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    PD 0200390, 5 mg
    Arm Type
    Experimental
    Arm Title
    PD 0200390, 15 mg
    Arm Type
    Experimental
    Arm Title
    PD 0200390, 30 mg
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.
    Intervention Type
    Drug
    Intervention Name(s)
    PD 0200390
    Intervention Description
    Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
    Intervention Type
    Drug
    Intervention Name(s)
    PD 0200390
    Intervention Description
    Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
    Intervention Type
    Drug
    Intervention Name(s)
    PD 0200390
    Intervention Description
    Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
    Primary Outcome Measure Information:
    Title
    Wake After Sleep Onset (WASO) as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Secondary Outcome Measure Information:
    Title
    Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ)
    Time Frame
    Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
    Title
    Latency to persistent sleep (LPS) as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Title
    Latency to REM Sleep as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Title
    Sleep efficiency (SE) as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Title
    Number of awakenings after sleep onset (NAASO) as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Title
    Total wake time (TWT) as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Title
    Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness
    Time Frame
    Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
    Title
    Number of arousals as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Title
    Total sleep time (TST) as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Title
    Next day performance sa determined by Digit Symbol Substitution Test (DSST)
    Time Frame
    Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
    Title
    Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ)
    Time Frame
    Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
    Title
    Wake time during sleep (WTDS) as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Title
    Wake time after sleep (WTAS) as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Title
    Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment
    Time Frame
    Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
    Title
    Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D)
    Time Frame
    Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 3 month history of primary insomnia Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening) Exclusion Criteria: Any history of psychiatric diagnosis History or presence of any breathing related sleep disorder History or presence of any medical or neurological condition that could interfere with sleep Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4251026&StudyName=A%20Dose-Ranging%2C%20Multicenter%20Polysomnography%20Trial%20of%20PD%200200390%20in%20Elderly%20Subjects%20With%20Primary%20Insomnia%0A
    Description
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    A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia

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