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Vestipitant 28-day Tolerance Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992160
First Posted: October 9, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
July 16, 2009
October 9, 2009
October 12, 2017
May 2009
September 2009   (Final data collection date for primary outcome measure)
Nocturnal polysomngraphy [ Time Frame: 6 weeks after start of treatment ]
Same as current
Complete list of historical versions of study NCT00992160 on ClinicalTrials.gov Archive Site
  • Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index [ Time Frame: 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 ]
  • Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index [ Time Frame: 6 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: 6 weeks after start of treatment ]
Not Provided
Not Provided
 
Vestipitant 28-day Tolerance Study
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Sleep Disorders
  • Drug: GW597599
    GW597599 15mg tablet
  • Drug: Placebo
    Placebo to match GW597599 15mg tablet
  • Experimental: Active
    Vestipitant 15mg once daily
    Intervention: Drug: GW597599
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
September 2009
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00992160
111364
Not Provided
Not Provided
Plan to Share IPD: Yes
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP