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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00748592
First received: September 5, 2008
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Insomnia
Drug: Placebo
Drug: PD 0200390
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Wake After Sleep Onset (WASO) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Latency to persistent sleep (LPS) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ] [ Designated as safety issue: No ]
  • Latency to REM Sleep as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ] [ Designated as safety issue: No ]
  • Sleep efficiency (SE) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Total wake time (TWT) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of arousals as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ] [ Designated as safety issue: No ]
  • Total sleep time (TST) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Wake time during sleep (WTDS) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ] [ Designated as safety issue: No ]
  • Wake time after sleep (WTAS) as determined by PSG assessment [ Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 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.
Experimental: PD 0200390, 5 mg 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.
Experimental: PD 0200390, 15 mg 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.
Experimental: PD 0200390, 30 mg 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748592

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00748592     History of Changes
Other Study ID Numbers: A4251026
Study First Received: September 5, 2008
Last Updated: February 11, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014