Last updated: 11/04/2018 09:03:20
Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 28 day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial.
Trial description: This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Latency to persistent sleep (LPS) based on polysomnograph (PSG) recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
Secondary outcomes:
Wake after sleep onset (WASO) based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
Total sleep time (TST) based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
Wake during sleep (WDS) based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
Wake after sleep (WAS) based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
Number of awakenings during sleep (NAASO) based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
REM sleep time based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
REM activity based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
REM density based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
Non-REM sleep time based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
Stage 2 non-REM sleep time based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
Slow wave sleep (SWS) time based on PSG recordings obtained on two consecutive nights over 28 days
Timeframe: Up to 28 days
Subjective total sleep time (sTST) measured by post-sleep questionnaire
Timeframe: Day 27 and 28
Subjective wake time after sleep onset (sWASO) measured by post-sleep questionnaire
Timeframe: Day 27 and 28
Subjective sleep onset latency (sSOL) measured by post-sleep questionnaire
Timeframe: Day 27 and 28
Number of awakenings measured by post-sleep questionnaire
Timeframe: Day 27 and 28
Sleep quality measured by post-sleep questionnaire
Timeframe: Day 27 and 28
Daytime alertness score measured using pre-sleep questionnaire during treatment over 28 days
Timeframe: Up to 28 days
Ability to function and well being score measured using pre-sleep questionnaire during treatment over 28 days
Timeframe: Up to 28 Days
Number of participants with any beverages containing caffeine, alcohol, who had food after 7 post meridiem (PM) and who had naps using pre-sleep questionnaire during treatment over 28 days
Timeframe: Up to 28 days
Digit symbol substitution test (DSST) score during treatment over 28 days
Timeframe: Up to 28 days
Total recall, delayed recall and recognition discrimination index (RDI) from Hopkins Verbal Learning Test–Revised (HVLT-R) during treatment over 28 days
Timeframe: Up to 28 days
Percentage of retention score of HVLT-R during treatment over 28 days
Timeframe: Up to 28 days
Number of participants who passed Romberg Test and Heel-To-Toe Test the first time they were attempted during treatment over 28 days
Timeframe: Up to 28 days
Total insomnia severity index (ISI) score
Timeframe: Up to Day 14 Follow-up
Benzodiazepine withdrawal symptom questionnaire version 2 (BWSQ-2) total score at Day 14 Follow-up
Timeframe: Day 14 Follow-up
Interventions:
Enrollment:
342
Primary completion date:
2007-21-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Insomnia, Sleep Initiation and Maintenance Disorders
Product
casopitant
Collaborators
Not applicable
Study date(s)
January 2006 to February 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 64 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.
- No nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
- Use of nicotine, caffeine and alcoholic products.
Trial location(s)
Location
GSK Investigational Site
Hinesville, Georgia, United States, 31313
Status
Study Complete
Location
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Parrry Sound, Ontario, Canada, P2A 1T3
Status
Study Complete
Location
GSK Investigational Site
Jupiter, Florida, United States, 33458
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Showing 1 - 6 of 78 Results
Study documents
Clinical study report
Available language(s): English
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
2007-21-02
Actual study completion date
2007-21-02
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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