Sleep Initiation and Maintenance DisordersPhase 2NCT00280423
Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia
A Phase 2 study testing GW679769 in people with Sleep Initiation and Maintenance Disorders and Insomnia, run by GlaxoSmithKline at 71 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Insomnia
- What is being tested?
- GW679769
- How many people
- 342 participants
- Where
- 71 sitesin 2 countries
- Study dates
- Jan 2006to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
71 sites in 2 countries.
71 sites in 2 countries
United States61 sites
GSK Investigational Site
Atlanta, Georgia, 30328
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Austin, Texas, 78756
GSK Investigational Site
Beachwood, Ohio, 44122
GSK Investigational Site
Bellaire, Texas, 77401
GSK Investigational Site
Birmingham, Alabama, 35213
GSK Investigational Site
Burbank, California, 91506
GSK Investigational Site
Chicago, Illinois, 60611
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Chicago, Illinois, 60634
GSK Investigational Site
Cincinnati, Ohio, 45227
GSK Investigational Site
Cincinnati, Ohio, 45246
GSK Investigational Site
Clarks Summit, Pennsylvania, 18411
GSK Investigational Site
Clementon, New Jersey, 08021
GSK Investigational Site
Cleveland, Ohio, 44130
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Crestview Hills, Kentucky, 41017
GSK Investigational Site
Dallas, Texas, 75251
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Delray Beach, Florida, 33484
GSK Investigational Site
Duncansville, Pennsylvania, 16635
GSK Investigational Site
Durham, North Carolina, 27705
GSK Investigational Site
Gainesville, Georgia, 30501
GSK Investigational Site
Gallipolis, Ohio, 45631
GSK Investigational Site
Gresham, Oregon, 97020
GSK Investigational Site
Hallandale, Florida, 33009
GSK Investigational Site
Hattiesburg, Mississippi, 39404
GSK Investigational Site
Hinesville, Georgia, 31313
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Huntington Beach, California, 92648
GSK Investigational Site
Irvine, California, 92618
GSK Investigational Site
Largo, Florida, 33773
GSK Investigational Site
Las Vegas, Nevada, 89104
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Macon, Georgia, 31201
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Miami, Florida, 33176
GSK Investigational Site
National City, California, 91950
GSK Investigational Site
Newton, Massachusetts, 02459
GSK Investigational Site
Norwalk, Connecticut, 06850
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Overland Park, Kansas, 66211
GSK Investigational Site
Pembroke Pines, Florida, 33026
GSK Investigational Site
Phoenix, Arizona, 85050
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Rockville, Maryland, 20852
GSK Investigational Site
Salisbury, North Carolina, 28144
GSK Investigational Site
Salt Lake City, Utah, 84107
GSK Investigational Site
San Diego, California, 92121
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
San Diego, California, 92161
GSK Investigational Site
San Francisco, California, 94105
GSK Investigational Site
Santa Rosa, California, 95405
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
Troy, Michigan, 48085
GSK Investigational Site
Tucson, Arizona, 85712
GSK Investigational Site
Warwick, Rhode Island, 02886
GSK Investigational Site
West Seneca, New York, 14224
GSK Investigational Site
Winston-Salem, North Carolina, 27157
Canada10 sites
GSK Investigational Site
Calgary, Alberta, T2X 2A8
GSK Investigational Site
Mississauga, Ontario, L5B4M4
GSK Investigational Site
Montreal, Quebec, H4J 1C5
GSK Investigational Site
Niagara Falls, Ontario, L2G 1J4
GSK Investigational Site
Parrry Sound, Ontario, P2A 1T3
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5
GSK Investigational Site
Toronto, Ontario, M4P 1P2
GSK Investigational Site
Toronto, Ontario, M5G 1E2
GSK Investigational Site
Toronto, Ontario, M5T3A9
GSK Investigational Site
Toronto, Ontario, M6J 3S3
About this study
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.
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.
- Being tested
- GW679769
- Keywords
- Cognition, Polysomnography, Primary Insomnia, Electroencephalography, Sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW679769Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep.
Measured: 28 Days
Secondary outcomes (1)
Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280423
- Sponsor's protocol ID
- MAD103894
- Status last verified
- Apr 2015
- First submitted
- 19 Jan 2006
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00280423
- Acronym / sponsor ID
- MAD103894
- Keywords
- Cognition, Polysomnography, Primary Insomnia, Electroencephalography, Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 23 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW679769 | Drug | – |
Primary outcome
Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep.
Time frame: 28 Days
1 secondary outcome
Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination.
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
71 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW679769 in people with Sleep Initiation and Maintenance Disorders and Insomnia, run by GlaxoSmithKline at 71 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep. (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.