Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime In Subjects With Primary Insomnia

April 14, 2015 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: GW679769

Study Type

Interventional

Enrollment (Actual)

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

France
- - Clamart, France, 92140
    - GSK Investigational Site
  - Paris Cedex 04, France, 75181
    - GSK Investigational Site
  - Rouffach, France, 68250
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10117
    - GSK Investigational Site
  - Berlin, Germany, 14050
    - GSK Investigational Site
  - Berlin, Germany, 13125
    - GSK Investigational Site
  - Berlin, Germany, 10559
    - GSK Investigational Site
- Bayern
  - Muenchen, Bayern, Germany, 81675
    - GSK Investigational Site
- Hessen
  - Schwalmstadt, Hessen, Germany, 34613
    - GSK Investigational Site
- Mecklenburg-Vorpommern
  - Schwerin, Mecklenburg-Vorpommern, Germany, 19053
    - GSK Investigational Site
- Niedersachsen
  - Goettingen, Niedersachsen, Germany, 37075
    - GSK Investigational Site
United States
- Arizona
  - Glendale, Arizona, United States, 85306
    - GSK Investigational Site
- California
  - Glendale, California, United States, 91204
    - GSK Investigational Site
- Florida
  - Hallandale Beach, Florida, United States, 33009
    - GSK Investigational Site
  - Miami, Florida, United States, 33137
    - GSK Investigational Site
- Georgia
  - Fayetteville, Georgia, United States, 30214
    - GSK Investigational Site
  - Hinesville, Georgia, United States, 31313
    - GSK Investigational Site
  - Suwanee, Georgia, United States, 30024
    - GSK Investigational Site
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - GSK Investigational Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - GSK Investigational Site
  - New Orleans, Louisiana, United States, 70115
    - GSK Investigational Site
- Massachusetts
  - Newton, Massachusetts, United States, 02459
    - GSK Investigational Site
- North Carolina
  - Fayetteville, North Carolina, United States, 28304
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73103
    - 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 to 64 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

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 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. Time Frame: 9 Days	9 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
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. Time Frame: 9 Days	9 Days

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

May 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria