Status:
COMPLETED
Orvepitant (GW823296) in Adult Post Traumatic Stress Disorder
Lead Sponsor:
GlaxoSmithKline
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
This is a 12-week, randomized, multicenter, double-blind, placebo controlled, fixed-dose parallel group study to assess the efficacy and safety of orvepitant (60 mg/day) versus placebo in subjects wit...
Detailed Description
The purpose of the current study is to test the safety and effects of orvepitant, an investigational drug for the treatment of noncombat-related PTSD. Efficacy will be assessed using standard symptom...
Eligibility Criteria
Inclusion
- Aged 18-64 years, inclusive.
- A primary diagnosis of noncombat-related Post traumatic Stress Disorder (PTSD)
- Subjects with symptom severity considered to be at least moderate to severe.
Exclusion
- Subjects whose symptoms are better accounted for by a diagnosis other than Post traumatic Stress Disorder (PTSD), subjects diagnosed with dementia; subjects diagnosed with a current/recent eating disorder such as anorexia nervosa or bulimia; subjects with a diagnosed history of schizophrenia, schizoaffective disorder, or Bipolar Disorder.
- Subjects who have a history of failing to respond to adequate treatment for PTSD with an antidepressant/anti-anxiety drug, i..e, failure to improve following administration of at least two other antidepressants/anti-anxiety drugs, each given for at least 4 weeks.
Key Trial Info
Start Date :
November 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2010
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01000493
Start Date
November 2 2009
End Date
June 28 2010
Last Update
September 1 2017
Active Locations (26)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35216
2
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
3
GSK Investigational Site
Beverly Hills, California, United States, 90210
4
GSK Investigational Site
Torrance, California, United States, 90502