Last updated: 11/04/2018 09:03:45

Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia

GSK study ID
MAD105514
See study documents
Clinicaltrials.gov ID
NCT00280436
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of GW679769 on polysomnographic sleep recordings, subjective sleep assessment, and daytime cognitive function in elderly and non-elderly subjects with primary insomnia
Trial description: This study is designed to find the optimal (best) doses of GW679769 that promote sleep onset and maintain sleep during two consecutive nights of dosing without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Latency to persistent sleep (LPS), as mean of PSG recordings obtained on two consecutive nights

Timeframe: Nights 1 and 2 of each treatment period (up to approximately 64 days)

Secondary outcomes:

Mean Total Sleep Time (TST) as objective PSG measures of sleep continuity.

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

Mean wake time after persistent sleep onset (WASO1) as objective PSG measures of sleep continuity.

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

Mean wake during sleep (WDS) as objective PSG measures of sleep continuity

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

Mean Wake after sleep (WAS) as Objective PSG measures of sleep continuity

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

Mean number of awakenings during sleep (NAASO) as Objective PSG measures of sleep continuity

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

Mean Non-Rapid Eye Movement (NREM) sleep time as objective PSG measures of sleep structure

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

Slow-Wave Sleep (SWS) time (stage 3 and 4) as objective PSG measures of sleep structure

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

Stage 2 non-REM sleep time (ST2) as objective PSG measures of sleep structure

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

REM sleep time as objective PSG measures of sleep structure.

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

REM activity as objective PSG measures of sleep structure

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

REM density as objective PSG measures of sleep structure

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

Sleep onset latency (sSOL) as subjective post-sleep measure

Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)

Mean sTST as subjective post-sleep measure

Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)

sWASO as subjective post-sleep measure

Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)

Number of awakenings as subjective post-sleep measure

Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)

Mean sleep quality completed each morning as subjective post-sleep measure.

Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)

Mean Morning Sleepiness Scores as subjective post-sleep measure

Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)

Mean daytime alertness as subjective pre-sleep measure

Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)

Number of participants with daytime naps as subjective pre-sleep measure at Day 1 and Day 2.

Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)

Digit Symbol Substitution Test (DSST) Score as daytime cognitive function tests on the morning following PSG recording.

Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)

Hopkins Verbal Learning Test (HVLT-R) as daytime cognitive function tests on the morning following PSG recording

Timeframe: Day 2 of each treatment period (Approximately up to 64 days)

Interventions:
  • Drug: GW679769
    • Enrollment:
    122
    Primary completion date:
    2007-07-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sleep Initiation and Maintenance Disorders, Insomnia
    Product
    casopitant
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to March 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Difficulty going to sleep and/or staying asleep for at least the past 3 months.
    • Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
    • History of other sleep disorders such as sleep apnea or restless leg syndrome.
    • Regular sleep habits, including bedtime between 9 PM and midnight.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Difficulty going to sleep and/or staying asleep for at least the past 3 months.
    • Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
    • Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis.
    Exclusion criteria:
    • History of other sleep disorders such as sleep apnea or restless leg syndrome.
    • Regular sleep habits, including bedtime between 9 PM and midnight.
    • Nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
    • Use to moderate use of nicotine, caffeine and alcoholic products.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Lincoln, Nebraska, United States, 68510
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Brandon, Florida, United States, 33511
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dannville, Indiana, United States, 45122
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Overland Park, Kansas, United States, 66211
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85050
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 30 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-07-03
    Actual study completion date
    2007-07-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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