Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00280423
First received: January 19, 2006
Last updated: November 1, 2012
Last verified: October 2012
  Purpose

This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Insomnia
Drug: GW679769
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep. [ Time Frame: 28 Days ]

Secondary Outcome Measures:
  • Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination. [ Time Frame: 28 Days ]

Enrollment: 321
Study Start Date: January 2006
Intervention Details:
    Drug: GW679769
    Other Name: GW679769
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • No nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
  • Use of nicotine, caffeine and alcoholic products.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280423

  Show 71 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00280423     History of Changes
Other Study ID Numbers: MAD103894
Study First Received: January 19, 2006
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Cognition
Polysomnography
Primary Insomnia
Electroencephalography
Sleep

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Casopitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014