A Study to Evaluate the Effects of GW679769 on Sleep and Cognitive Function in Subjects With Primary Insomnia

NCT00650871 | Completed Phase 2

• 1 other identifier: GW679769/903
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 7

Brief Summary

A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects participate in a clinical screening visit and a two-night PSG recording session in the sleep laboratory. Eligible subjects then participate in three separate two-night PSG sessions in which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior to bedtime, one treatment for each session in a balanced order. Each treatment session is separated by a two-week drug-free period and occur on the same day of the week. A safety follow-up visit occurs 2 weeks after the last treatment session.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

sleep,; polysomnography.; GW679769,; primary insomnia,; cognitive function,

Outcome Measures

Primary Outcomes (1)

• Mean Wake time after sleep onset (WASO) derived from PSG recording

  WASO was measured from persistent sleep onset to lights on. It was calculated as number of wake epochs from persistent sleep onset to lights on divided by 2. WASO measures was analyzed using a mixed effect model with session and treatment as fixed effect and participants as random effect.

  Night 1 and 2 of each treatment period (Approximately up to 31 Days)

Secondary Outcomes (20)

• Mean total sleep time (TST) as objective PSG measures of sleep continuity

  Night 1 and 2 of each treatment period (Approximately up to 31 days)

• Mean latency to persistent sleep (LPS) as objective PSG measures of sleep continuity

  Night 1 and 2 of each treatment period (approximately 31 days)

• Mean wake during sleep (WDS) as objective PSG measures of sleep continuity

  Night 1 and 2 of each treatment period (Approximately up to 31 days)

• Mean wake after sleep (WAS) as objective PSG measures of sleep continuity

  Night 1 and 2 of each treatment period (Approximately up to 31 days)

• Mean number of 1 minute awakenings during sleep as objective PSG measures of sleep continuity

  Night 1 and 2 of each treatment period (Approximately up to 31 days)

Interventions

GW679769 DRUG

Placebo DRUG

Also known as: GW679769

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• clinically significant physical or psychiatric illness or abnormal sleep patterns.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

San Diego, California, 92123, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

New York, New York, 10025, United States

Location

GSK Investigational Site

Durham, North Carolina, 27705, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27157, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45246, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

casopitant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: July 30, 2004
• Primary Completion: August 30, 2005
• Study Completion: August 30, 2005
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

US (7)