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
Completed
Completed
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:
Drug: GW679769
Enrollment:
342
Observational study model:
Not applicable
Primary completion date:
2007-21-02
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
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20852
Status
Study Complete
Location
GSK Investigational Site
Crestview Hills, Kentucky, United States, 41017
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92101
Status
Study Complete
Location
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60634
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Georgia, United States, 30501
Status
Study Complete
Location
GSK Investigational Site
Santa Rosa, California, United States, 95405
Status
Study Complete
Location
GSK Investigational Site
Hattiesburg, Mississippi, United States, 39404
Status
Study Complete
Location
GSK Investigational Site
National City, California, United States, 91950
Status
Study Complete
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92121
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Status
Study Complete
Location
GSK Investigational Site
Burbank, California, United States, 91506
Status
Study Complete
Location
GSK Investigational Site
Clarks Summit, Pennsylvania, United States, 18411
Status
Study Complete
Location
GSK Investigational Site
Hallandale Beach, Florida, United States, 33009
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33026
Status
Study Complete
Location
GSK Investigational Site
Clementon, New Jersey, United States, 08021
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45227
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35213
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92648
Status
Study Complete
Location
GSK Investigational Site
Irvine, California, United States, 92618
Status
Study Complete
Location
GSK Investigational Site
Virginia Beach, Virginia, United States, 23452
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94105
Status
Study Complete
Location
GSK Investigational Site
West Seneca, New York, United States, 14224
Status
Study Complete
Location
GSK Investigational Site
Encinitas, California, United States, 92024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30328
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27705
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92161
Status
Study Complete
Location
GSK Investigational Site
Norwalk, Connecticut, United States, 06850
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
Status
Study Complete
Location
GSK Investigational Site
Niagara Falls, Ontario, Canada, L2G 1J4
Status
Study Complete
Location
GSK Investigational Site
Newton, Massachusetts, United States, 02459
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
Delray Beach, Florida, United States, 33484
Status
Study Complete
Location
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Morristown, Tennessee, United States, 37813
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Gallipolis, Ohio, United States, 45631
Status
Study Complete
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
Completed
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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