Orvepitant (GW823296) in Adult Post Traumatic Stress Disorder
Public ClinicalTrials.gov record NCT01000493. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose Study Evaluating the Efficacy and Safety of the Neurokinin-1 Receptor Antagonist Orvepitant (GW823296) in Post Traumatic Stress Disorder (PTSD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 with a diagnosis of noncombat-related Posttraumatic Stress Disorder (PTSD), whose symptoms are considered moderate or severe. Following an initial screening visit, subjects fulfilling the study inclusion and exclusion criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory and ECG assessments and to confirm eligibility for inclusion into the study. This screening phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the screening period, eligible subjects will be randomized at the baseline visit to receive either orvepitant 60mg/day or placebo (1:1 ratio). Those subjects randomized to receive placebo will receive study medication identical in appearance to that received by subjects assigned to receive orvepitant. Efficacy will be assessed using the Clinician Administered PTSD Scale (CAPS) as the primary efficacy measure. Key secondary efficacy endpoints will be based on the Davidson Trauma Scale (DTS), the Short PTSD Rating Interview (SPRINT), the Clinical Global Impression- Global Improvement and Severity of Illness Scales (CGI-I and CGI-S, respectively), the Hamilton Depression Rating Scale (HAM-D), the Cognitive and Physical Functioning Questionnaire (CPFQ) and the Pittsburgh Sleep Quality Index (PSQI). Safety will be assessed by monitoring for adverse events (side effects) and through periodic laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart rate, temperature) and heart function measurements (electrocardiograms, or ECGs).
Study identification
- NCT ID
- NCT01000493
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2, 2009 (Actual)
- Primary completion
- Jun 28, 2010 (Actual)
- Completion
- Jun 28, 2010 (Actual)
- Last update posted
- Sep 1, 2017
2009 – 2010
United States locations
- U.S. sites
- 26
- U.S. states
- 20
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35216 | — |
| GSK Investigational Site | Scottsdale | Arizona | 85251 | — |
| GSK Investigational Site | Beverly Hills | California | 90210 | — |
| GSK Investigational Site | Torrance | California | 90502 | — |
| GSK Investigational Site | Jacksonville | Florida | 32216 | — |
| GSK Investigational Site | Orlando | Florida | 32806 | — |
| GSK Investigational Site | Marietta | Georgia | 30060 | — |
| GSK Investigational Site | Park Ridge | Illinois | 60068 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46260 | — |
| GSK Investigational Site | Glen Burnie | Maryland | 21061 | — |
| GSK Investigational Site | Weymouth | Massachusetts | 02190 | — |
| GSK Investigational Site | Willingboro | New Jersey | 08046 | — |
| GSK Investigational Site | The Bronx | New York | 10467 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | — |
| GSK Investigational Site | Dayton | Ohio | 45417 | — |
| GSK Investigational Site | Garfield Heights | Ohio | 44125 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | — |
| GSK Investigational Site | Charleston | South Carolina | 29403 | — |
| GSK Investigational Site | Memphis | Tennessee | 38119 | — |
| GSK Investigational Site | Austin | Texas | 78756 | — |
| GSK Investigational Site | Dallas | Texas | 75231 | — |
| GSK Investigational Site | Houston | Texas | 77008 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84132-2502 | — |
| GSK Investigational Site | Seattle | Washington | 98104 | — |
| GSK Investigational Site | Brown Deer | Wisconsin | 53223 | — |
| GSK Investigational Site | Middleton | Wisconsin | 53562 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01000493, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2017 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01000493 live on ClinicalTrials.gov.