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Disturbed Sleep Model Study.

NCT00440323 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2017-08-17

No results posted yet for this study

Summary

Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG nights, study drug administration and noise model is conducted on second night.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DRUG

SB-649868

SB-649868 tablets will be available with dose strength of 5 and 25 mg.

DRUG

Zolpidem

Zolpidem capsules will be available with dose strength of 10 mg.

DRUG

Placebo

Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-05
Primary Completion
2007-07-03
Completion
2007-07-03

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00440323 on ClinicalTrials.gov