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View Clinical Trial (Medical Research Study)
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Orvepitant (GW823296) in Adult Post Traumatic Stress Disorder - NCT01000493-08046 (Clinical Trial 476791)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy476791.aspx
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| City: |
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Willingboro |
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State:
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NJ |
| Zip Code: |
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08046 |
| Conditions: |
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Posttraumatic Stress Disorder (PTSD) |
| Purpose: |
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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).
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| Study summary: |
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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 and severity rating scales
(questionnaires). The Clinicain Adminstered PTSD Scale (CAPS) will serve as the primary
measure of efficacy. Secondary efficacy endpoints include the CAPS subscale clusters
(Re-Experiencing, Avoidance and Numbing, and Hyperarousal), the Davidson Trauma Scale (DTS),
the Short PTSD Rating Interview (SPRINT), the Hamilton Depression Rating Scale (HAM-D), the
Clinical Global Impression- Global Improvement and Severity of Illness Scale (CGI-I and
CGI-S, respectively), the Cognitive and Physical Functioning Questionnaire (CPFQ) and the
Pittsburgh Sleep Quality Index (PSQI).
Safety and tolerability will be assessed by monitoring adverse events (AEs or side effects),
physical examinations (including vital signs such as blood pressure and heart rate),
clinical laboratory assessments (blood tests), electrical recordings of the heart
(electrocardiograms or ECG's), the Columbia Suicidality Severity Rating Scale (CSSRS),
Massachusetts Sexual Function Questionnaire (MSFQ), Discontinuation-Emergent Signs and
Symptoms (DESS) scale and weight change.
Blood samples will be taken at different time points to assess blood levels of orvepitant in
patients, allowing the relationship between amount of orvepitant in the body and efficacy to
be studied.
The primary objective of the study is to evaluate the efficacy of orvepitant (60mg/day)
versus placebo (a "sugar pill", with no active ingredients). The secondary objectives
include assessing the safety and tolerability of orvepitant, assessing the profile of
appearance and disappearance of orvepitant in the body (blood) following administration
(i.e., assessing how long the drug remains in the body), and lastly to examine the
relationship between blood levels of the drug and efficacy (i..e, the change in CAPS score
relative to what it was before starting the study medication).
Following an initial screening visit, subjects fulfilling the study entrance criteria will
enter a pre-treatment screening phase to permit evaluation of the laboratory and
electrocardiogram 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. Upon completion of
the screening period, eligible subjects will be randomly assigned at the baseline visit to
one of two treatment regimens: orvepitant 60mg/day or placebo for a 12-week treatment phase.
The chances of receiving each of the two possible treatments will be equal. Orvepitant will
be administered as tablets. Those subjects randomised to receive placebo will receive study
medication identical in appearance to that received by subjects assigned to receive
orvepitant.
During the treatment phase, subjects will be required to return to the clinic at the end of
Weeks 1, 2, 4, 6, 8, 10 and 12. In addition, all subjects will be required to return for a
follow-up visit 14 days after the last dose of study medication. In addition, all subjects
with ongoing adverse events at the 14-day follow-up visit will be required to return for a
further follow-up visit 28 days after the last dose of study medication. Women of
child-bearing potential will also be required to attend the 28-Day follow-up visit for a
pregnancy test. A further test will be performed 42 Days following the end of treatment.
Male and female outpatients between the ages of 18 to 64 years inclusive with a primary
diagnosis of noncombat-related PTSD will be enrolled into this study. A total of
approximately 240 subjects are expected to be enrolled at approximately 25 different study
sites in North America. |
| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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. |
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| Study is available at: |
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GSK Investigational Site
Willingboro, NJ 08046
United States
Primary Contact:
US GSK Clinical Trials Call Center
Phone: 877-379-3718 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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