Vestipitant 28-day Tolerance Study

October 26, 2016 updated by: GlaxoSmithKline

A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/Day) for the Treatment of Primary Insomnia in Adult Outpatients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 10115
        • GSK Investigational Site
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 10629
        • GSK Investigational Site
      • Berlin, Germany, 10787
        • GSK Investigational Site
      • Hamburg, Germany, 20246
        • GSK Investigational Site
      • Hamburg, Germany, 20253
        • GSK Investigational Site
    • Hessen
      • Kassel, Hessen, Germany, 34131
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
        • GSK Investigational Site
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19053
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo to match GW597599 15mg tablet
Experimental: Active
Vestipitant 15mg once daily
Drug: GW597599
GW597599 15mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nocturnal polysomngraphy
Time Frame: 6 weeks after start of treatment
6 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index
Time Frame: 4 weeks after start of treatment
4 weeks after start of treatment
Motor and cognitive functioning assessed by neurological tests (Romberg and Hee-to-toe) and Cognitive tests (Digit Symbol Substitution test and verbal Learning Memory test)
Time Frame: 4 weeks after start of treatment
4 weeks after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (Estimate)

October 9, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111364

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Clinical Study Report
    Information identifier: 111364
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: 111364
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 111364
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 111364
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annotated Case Report Form
    Information identifier: 111364
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: 111364
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: 111364
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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