Vestipitant 28-day Tolerance Study

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

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.

Detailed Description

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Conditions

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Sleep Disorders

Keywords

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Polysomnography (PSG) Adults Primary Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

Vestipitant 15mg once daily

Group Type EXPERIMENTAL

GW597599

Intervention Type DRUG

GW597599 15mg tablet

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match GW597599 15mg tablet

Interventions

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GW597599

GW597599 15mg tablet

Intervention Type DRUG

Placebo

Placebo to match GW597599 15mg tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders -Text Revision (DSM-IV-TR) criteria 307.42
* PSG variables collected during 2consecutive PSG screening nights falling as follows: TST between 240-420 mins inclusive (both nights) - LPS (Latency to Persistent Sleep): mean not less than 20mins, each night not less than 15 mins - WASO (Wake After Sleep Onset): mean not less than 60mins, each night not less than 45mins
* Women: non child bearing potential or if child bearing potential agree on Contraceptive Methods listed in Protocol

Exclusion Criteria

* clinically significant Psychiatric and neurological disorders (sleep disorders other than Primary Insomnia, history of alcohol orother substance abuse or dependnce);
* nightshift or rotating shift-work;
* Lifestyle habits in agreement with Protocol requirement: caffeine - alcohol intake and smoke
* healthy according to GSK criteria - laboratory and ECG limits set in the Protocol

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Kassel, Hesse, Germany

Site Status

GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status