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

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ClinicalTrials.gov Identifier: NCT00748592
Recruitment Status : Withdrawn
First Posted : September 8, 2008
Last Update Posted : February 12, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 5, 2008
First Posted Date  ICMJE September 8, 2008
Last Update Posted Date February 12, 2009
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2008)
Wake After Sleep Onset (WASO) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2008)
Wake After Sleep Onset (WASO) as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
Change History Complete list of historical versions of study NCT00748592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2008)
  • 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 ]
  • Latency to persistent sleep (LPS) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Latency to REM Sleep as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Sleep efficiency (SE) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • 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 ]
  • Total wake time (TWT) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • 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 ]
  • Number of arousals as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Total sleep time (TST) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • 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 ]
  • 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 ]
  • Wake time during sleep (WTDS) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Wake time after sleep (WTAS) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2008)
  • Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ) [ Time Frame: This endpoint will be measured at days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 ]
  • Wake time during sleep (WTDS) as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Wake time after sleep (WTAS) as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ) [ Time Frame: This endpoint will be measured at days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 ]
  • Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D) [ Time Frame: This endpoint will be measured at days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 ]
  • Sleep efficiency (SE) as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Total wake time (TWT) as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness [ Time Frame: This endpoint will be measured at days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 ]
  • Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Latency to REM Sleep as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Latency to persistent sleep (LPS) as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Number of awakenings after sleep onset (NAASO) as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Number of arousals as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Total sleep time (TST) as determined by PSG assessment [ Time Frame: This endpoint will be measured at days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ]
  • Next day performance sa determined by Digit Symbol Substitution Test (DSST) [ Time Frame: This endpoint will be measured at days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • Drug: Placebo
    Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.
  • Drug: PD 0200390
    Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
  • Drug: PD 0200390
    Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
  • Drug: PD 0200390
    Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PD 0200390, 5 mg
    Intervention: Drug: PD 0200390
  • Experimental: PD 0200390, 15 mg
    Intervention: Drug: PD 0200390
  • Experimental: PD 0200390, 30 mg
    Intervention: Drug: PD 0200390
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 11, 2009)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2008)
32
Estimated Study Completion Date  ICMJE June 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00748592
Other Study ID Numbers  ICMJE A4251026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP