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To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia

NCT ID: NCT00426816

Last Updated: 2012-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-05-31

Brief Summary

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This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity, PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects with primary insomnia

Detailed Description

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Conditions

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Sleep Initiation and Maintenance Disorders

Keywords

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primary insomnia PSG sleep recordings daytime cognitive function Insomnia SB-649868

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Crossover population

All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing

Group Type EXPERIMENTAL

SB-649868

Intervention Type DRUG

Active compound at doses of 10mg, 30mg and 60mg

Placebo

Intervention Type DRUG

Placebo to match SB-649868

Interventions

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SB-649868

Active compound at doses of 10mg, 30mg and 60mg

Intervention Type DRUG

Placebo

Placebo to match SB-649868

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male
* 18-64 years of age (inclusive),
* Diagnosis of primary insomnia who have had symptoms for at least three months.

Exclusion Criteria

* Any clinically significant unstable medical or surgical condition (treated or untreated).
* Any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure).
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Cottbus, Brandenburg, Germany

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Dortmund, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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OXS107714

Identifier Type: -

Identifier Source: org_study_id