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

Primary Purpose

Sleep Initiation and Maintenance Disorders, Insomnia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW679769
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring cognition, Primary Insomnia, sleep, polysomnography

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 18, 2006
Last Updated
April 14, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00354809
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Insomnia
Keywords
cognition, Primary Insomnia, sleep, polysomnography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW679769
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
GSK Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
GSK Investigational Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
GSK Investigational Site
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
GSK Investigational Site
City
Hinesville
State/Province
Georgia
ZIP/Postal Code
31313
Country
United States
Facility Name
GSK Investigational Site
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
GSK Investigational Site
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
GSK Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
GSK Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
GSK Investigational Site
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
GSK Investigational Site
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
GSK Investigational Site
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 04
ZIP/Postal Code
75181
Country
France
Facility Name
GSK Investigational Site
City
Rouffach
ZIP/Postal Code
68250
Country
France
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
GSK Investigational Site
City
Schwalmstadt
State/Province
Hessen
ZIP/Postal Code
34613
Country
Germany
Facility Name
GSK Investigational Site
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19053
Country
Germany
Facility Name
GSK Investigational Site
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany

12. IPD Sharing Statement

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

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