Clinical trial NCT00280436: Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Initiation and Maintenance Disorders
Insomnia
Keywords: Polysomnography
Electroencephalography
Primary Insomnia
Cognition
Sleep
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-01-23
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Comparison of GW679769 and placebo on the average time needed to fall asleep after bedtime dosing on two consecutive nights, as assessed by electroencephalography and other physiological changes during sleep.
timeFrame: 48 Hours
Secondary outcomes:
measure: Comparison of GW679769 and placebo on sleep maintenance and duration after bedtime dosing on two consecutive nights, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination.
timeFrame: 48 Hours
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Glendale
country: United States
facility: GSK Investigational Site
state: California
city: Glendale
country: United States
facility: GSK Investigational Site
state: California
city: Redlands
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Brandon
country: United States
facility: GSK Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: GSK Investigational Site
state: Florida
city: Naples
country: United States
facility: GSK Investigational Site
state: Florida
city: Spring Hill
country: United States
facility: GSK Investigational Site
state: Florida
city: Austell
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Northfield
country: United States
facility: GSK Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: GSK Investigational Site
state: Kansas
city: Chevy Chase
country: United States
facility: GSK Investigational Site
state: Maryland
city: Frederick
country: United States
facility: GSK Investigational Site
state: Maryland
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Lafayette Hill
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Anderson
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Fairfax
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: