Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia

April 14, 2015 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85710
        • GSK Investigational Site
    • California
      • Anaheim, California, United States, 92805
        • GSK Investigational Site
      • Glendale, California, United States, 91204
        • GSK Investigational Site
      • Glendale, California, United States, 91206
        • GSK Investigational Site
      • Redlands, California, United States, 92373
        • GSK Investigational Site
      • San Diego, California, United States, 92103
        • GSK Investigational Site
      • San Diego, California, United States, 92123
        • GSK Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • GSK Investigational Site
      • Kissimmee, Florida, United States, 34741
        • GSK Investigational Site
      • Naples, Florida, United States, 34110
        • GSK Investigational Site
      • Spring Hill, Florida, United States, 34609
        • GSK Investigational Site
    • Georgia
      • Austell, Georgia, United States, 30106
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • GSK Investigational Site
      • Northfield, Illinois, United States, 60093
        • GSK Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • GSK Investigational Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • GSK Investigational Site
      • Frederick, Maryland, United States, 21702
        • GSK Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Pennsylvania
      • Lafayette Hill, Pennsylvania, United States, 19444
        • GSK Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • GSK Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • GSK Investigational Site
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 48 Hours
48 Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 48 Hours
48 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimate)

January 23, 2006

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAD105514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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