Status:
COMPLETED
Vestipitant 28-day Tolerance Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Sleep Disorders
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00992160
Start Date
May 1 2009
End Date
September 1 2009
Last Update
October 28 2016
Active Locations (13)
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1
GSK Investigational Site
Hamburg, Hamburg, Germany, 20246
2
GSK Investigational Site
Hamburg, Hamburg, Germany, 20253
3
GSK Investigational Site
Kassel, Hesse, Germany, 34131
4
GSK Investigational Site
Hanover, Lower Saxony, Germany, 30159