Clinical trial NCT00354809: Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime In Subjects With Primary Insomnia
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Morning Administration of GW679769 (10mg and 30 mg) on Polysomnograph Sleep Recordings, Subjective Sleep Assessment, Daytime Cognition and Psychomotor Function in Subjects With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Initiation and Maintenance Disorders
Insomnia
Keywords: cognition
Primary Insomnia
sleep
polysomnography
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9 days, will promote sleep during the following night without significant post-dose thinking impairment and drowsiness in subjects with primary insomnia.


Eligibility criteria: Inclusion criteria:

* Difficulty going to sleep and/or staying asleep during 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 when taken daily in the morning, on the time needed to fall asleep at bedtime on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic.
timeFrame: 9 Days
Secondary outcomes:
measure: Comparison of GW679769 and placebo on total sleep time and time awake after initial sleep onset on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic. Daily sleep questionnaires and mental functioning tests on Days 1 and 9 of treatment.
timeFrame: 9 Days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Glendale
country: United States
facility: GSK Investigational Site
state: California
city: Hallandale Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Hinesville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Suwanee
country: United States
facility: GSK Investigational Site
state: Georgia
city: Crestview Hills
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Newton
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Clamart
country: France
facility: GSK Investigational Site
city: Paris Cedex 04
country: France
facility: GSK Investigational Site
city: Rouffach
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Schwalmstadt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Goettingen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: