Last updated: 11/04/2018 06:04:01

Treatment Of Patients With Social Anxiety Disorder

GSK study ID
CRH103390
See study documents
Clinicaltrials.gov ID
NCT00397722
See results summary
EudraCT ID
2006-003597-10
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2007-05-09
    Observational study model:
    Not applicable
    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
    • Inclusion criteria:
    • are diagnosed with generalized social anxiety disorder/social phobia.
    Inclusion and exclusion criteria
    Inclusion 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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    GÖTEBORG, Sweden, SE-416 85
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    New York, New York, United States, 10024
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hamar, Norway, 2301
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Rauma, Finland, 26100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Turku, Finland, 20100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33173
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 33 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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