NCT00354809

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
3 countries

24 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

May 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

July 18, 2006

Last Update Submit

April 14, 2015

Conditions

Sleep Initiation and Maintenance DisordersInsomnia

Keywords

cognitionPrimary Insomniasleeppolysomnography

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 Days

Secondary Outcomes (1)

  • 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.

    9 Days

Interventions

GW679769DRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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 (24)

GSK Investigational Site

Glendale, Arizona, 85306, United States

Location

GSK Investigational Site

Glendale, California, 91204, United States

Location

GSK Investigational Site

Hallandale, Florida, 33009, United States

Location

GSK Investigational Site

Miami, Florida, 33137, United States

Location

GSK Investigational Site

Fayetteville, Georgia, 30214, United States

Location

GSK Investigational Site

Hinesville, Georgia, 31313, United States

Location

GSK Investigational Site

Suwanee, Georgia, 30024, United States

Location

GSK Investigational Site

Crestview Hills, Kentucky, 41017, United States

Location

GSK Investigational Site

Baton Rouge, Louisiana, 70809, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, United States

Location

GSK Investigational Site

Newton, Massachusetts, 02459, United States

Location

GSK Investigational Site

Fayetteville, North Carolina, 28304, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

GSK Investigational Site

Clamart, 92140, France

Location

GSK Investigational Site

Paris, 75181, France

Location

GSK Investigational Site

Rouffach, 68250, France

Location

GSK Investigational Site

Munich, Bavaria, 81675, Germany

Location

GSK Investigational Site

Schwalmstadt, Hesse, 34613, Germany

Location

GSK Investigational Site

Göttingen, Lower Saxony, 37075, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19053, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10559, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13125, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 14050, Germany

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

July 18, 2006

First Posted

July 20, 2006

Study Start

May 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

US(13)FR(3)DE(8)