NCT00280436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

January 19, 2006

Last Update Submit

April 14, 2015

Conditions

Sleep Initiation and Maintenance DisordersInsomnia

Keywords

PolysomnographyElectroencephalographyPrimary InsomniaCognitionSleep

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 Hours

Secondary Outcomes (1)

  • 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.

    48 Hours

Interventions

GW679769DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

GSK Investigational Site

Phoenix, Arizona, 85050, United States

Location

GSK Investigational Site

Tucson, Arizona, 85710, United States

Location

GSK Investigational Site

Anaheim, California, 92805, United States

Location

GSK Investigational Site

Glendale, California, 91204, United States

Location

GSK Investigational Site

Glendale, California, 91206, United States

Location

GSK Investigational Site

Redlands, California, 92373, United States

Location

GSK Investigational Site

San Diego, California, 92103, United States

Location

GSK Investigational Site

San Diego, California, 92123, United States

Location

GSK Investigational Site

Brandon, Florida, 33511, United States

Location

GSK Investigational Site

Kissimmee, Florida, 34741, United States

Location

GSK Investigational Site

Naples, Florida, 34110, United States

Location

GSK Investigational Site

Spring Hill, Florida, 34609, United States

Location

GSK Investigational Site

Austell, Georgia, 30106, United States

Location

GSK Investigational Site

Chicago, Illinois, 60634, United States

Location

GSK Investigational Site

Northfield, Illinois, 60093, United States

Location

GSK Investigational Site

Overland Park, Kansas, 66211, United States

Location

GSK Investigational Site

Chevy Chase, Maryland, 20815, United States

Location

GSK Investigational Site

Frederick, Maryland, 21702, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68510, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27612, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Lafayette Hill, Pennsylvania, 19444, United States

Location

GSK Investigational Site

Warwick, Rhode Island, 02886, United States

Location

GSK Investigational Site

Anderson, South Carolina, 29621, United States

Location

GSK Investigational Site

Austin, Texas, 78756, United States

Location

GSK Investigational Site

Fairfax, Virginia, 22030, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

casopitant

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2006

First Posted

January 23, 2006

Study Start

January 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

US(26)