Last updated: 11/04/2018 06:04:01
Treatment Of Patients With Social Anxiety Disorder
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study CRH103390: A 12 Week Flexible Dose Study of GW876008, Placebo and Active Control (Paroxetine) in the Treatment of Social Anxiety Disorder (SocAD)
Trial description: GW876008 is a drug which may change mans reaction to stress, by decreasing the fear, physical and behavior symptoms that people with SocAD experience in social situations.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Change from randomization in the clinician-administered Liebowitz Social Anxiety Scale total score at the end of the treatment phase (Week 12)
Timeframe: Baseline (Day 0) and Week 12
Change from randomization on the fear subscale score at Week 12
Timeframe: Baseline (Day 0) Week 12
Change from randomization on the Liebowitz Social Anxiety Scale Avoidance subscale score at Week 12
Timeframe: Baseline (Day 0) and Week 12
Change from randomization on the Social Avoidance and Distress Scale (SADS) total score at Week 12
Timeframe: Baseline (Day 0) and Week 12
Secondary outcomes:
Number of participants with abnormal electrocardiogram (ECG) findings any time post randomization
Timeframe: Up to Week 12
Change from Randomization in Vital Signs: systolic and diastolic blood pressure (SBP and DBP)
Timeframe: Baseline (Day 0) Up to Week 12
Change from Randomization in vital signs : heart rate
Timeframe: Baseline (Day 0) and up to Week 12
Number of participants with chemistry data outside the normal range (Any time post-Randomization)
Timeframe: Up to Week 12
Number of participants with hematology data outside the normal range (Any time post-Randomization)
Timeframe: Up to Week 12
Number of participants with All adverse events (AE) and serious adverse events SAE)
Timeframe: Up to 18 Weeks
Trough Concentration (Ctrough)
Timeframe: Pre-dose (0.0 hr) at Week 1, Week 2, Week 4, Week 8 and Week 12.
Exposure at steady state (AUC (0-τ))
Timeframe: Pre-dose (0.0 hr) at Week 1, Week 2, Week 4, Week 8 and Week 12
Interventions:
Drug: GW876008
Drug: paroxetine
Enrollment:
299
Observational study model:
Not applicable
Primary completion date:
2007-05-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Social Phobia
Product
emicerfont, paroxetine
Collaborators
Not applicable
Study date(s)
November 2006 to September 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
No
- are diagnosed with generalized social anxiety disorder/social phobia.
- have a diagnosis of major depressive disorder
- have a history of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder.
Inclusion and exclusion criteria
Inclusion criteria:
- are diagnosed with generalized social anxiety disorder/social phobia.
Exclusion criteria:
- have a diagnosis of major depressive disorder
- have a history of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder.
Trial location(s)
Location
GSK Investigational Site
New York, New York, United States, 10024
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20852
Status
Study Complete
Location
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
Status
Study Complete
Location
GSK Investigational Site
Media, Pennsylvania, United States, 19063
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 2H4
Status
Study Complete
Location
GSK Investigational Site
Observatory ,Cape Town, South Africa, 7925
Status
Study Complete
Location
GSK Investigational Site
Oakbrook Terrace, Illinois, United States, 60181
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Study Complete
Location
GSK Investigational Site
Tygerberg, Eastern Cape, South Africa, 7505
Status
Study Complete
Location
GSK Investigational Site
Nutley, New Jersey, United States, 07110
Status
Study Complete
Location
GSK Investigational Site
Westerstede, Niedersachsen, Germany, 26655
Status
Study Complete
Location
GSK Investigational Site
Burbank, California, United States, 91506
Status
Study Complete
Location
GSK Investigational Site
Temecula, California, United States, 92591
Status
Study Complete
Location
GSK Investigational Site
Farmington Hills, Michigan, United States, 48336
Status
Study Complete
Location
GSK Investigational Site
Miramichi, New Brunswick, Canada, E1V 3G5
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-05-09
Actual study completion date
2007-05-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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