Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Vestipitant 28-day Tolerance Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00992160
First received: July 16, 2009
Last updated: March 22, 2012
Last verified: March 2012

July 16, 2009
March 22, 2012
May 2009
September 2009   (final data collection date for primary outcome measure)
Nocturnal polysomngraphy [ Time Frame: 6 weeks after start of treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index [ Time Frame: 6 weeks after start of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Sleep Disorders
  • Primary Insomnia
  • 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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00992160
111364
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2012

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