Last updated: 11/04/2018 09:41:57

A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder

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GSK study ID
NKF100110
See study documents
Clinicaltrials.gov ID
NCT00273039
See results summary
EudraCT ID
2005-001336-77
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: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects with Social Anxiety Disorder
Trial description: The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS) total score at the Week 12 last observation carried forward (LOCF).

Timeframe: Baseline (Week 0) and Week 12

Secondary outcomes:

Percentage of participants who scored 1 or 2 (very much improved or much improved) on the Clinical Global Impression Global Improvement (CGI-I) item at Week 12 LOCF

Timeframe: Week 12

Change from Baseline in the Clinical Global Impression Severity of Illness (CGI-S) item score at Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the LSAS Fear subscale score at the Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the LSAS Avoidance subscale score at the Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the Sheehan Disability Scale (SDS) total score at the Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the SDS family life item at the Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the SDS work item at the Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the SDS social life item at the Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the Medical Outcomes Study (MOS) 12-item Sleep Module (sum of 9 items) at the Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the Leeds Sleep Evaluation Questionnaire (LSEQ) Getting to Sleep subscale score at the Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the LSEQ Quality of Sleep subscale score at the Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the LSEQ Awakening from Sleep subscale score at the Week 12 LOCF

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline on the LSEQ Behavior Following Wakefulness subscale score at the Week 12

Timeframe: Baseline (Week 0) and Week 12

Percentage of participants assessed for Satisfaction with Study Medication at the Week 12 LOCF

Timeframe: Week 12

Number of participants with adverse events (AE) and serious adverse events (SAE)

Timeframe: Upto Week 12

Number of participants with adverse events leading to study withdrawal

Timeframe: Upto Week 12

Number of participants with clinical chemistry data outside the reference range of potential clinical concern (PCC) any time on treatment (ATOT)

Timeframe: Upto Week 12

Number of participants with hematology data outside the reference range of PCC ATOT

Timeframe: Upto Week 12

Number of participants with vital signs data for systolic blood pressure, diastolic blood pressure, heart rate and body weight of PCC ATOT

Timeframe: Upto Week 12

Number of participants with abnormal urinalysis results confirmed by dipstick analysis

Timeframe: Upto Week 12

Number of participants with abnormal electrocardiogram (ECG) findings ATOT defined by clinical significance

Timeframe: Upto Week 12

Interventions:
  • Drug: Paroxetine 20-30 mg/Day
  • Drug: Casopitant 80-120 mg/Day
  • Drug: Casopitant 20-30 mg/Day
  • Drug: Placebo of Paroxetine 20-30 mg/Day
  • Drug: Placebo of Casopitant 80-120 mg/Day
  • Drug: Placebo of Casopitant 20-30 mg/Day
    • Enrollment:
    238
    Primary completion date:
    2006-28-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Anxiety Disorders
    Product
    casopitant, paroxetine
    Collaborators
    Not applicable
    Study date(s)
    August 2005 to September 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Patients with Generalized Social Anxiety Disorder as the primary diagnosis.
    • If female, must commit to consistent and correct use of an acceptable method of birth control.
    • Patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening.
    • Patients with Body Dysmophic Disorder, Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with Generalized Social Anxiety Disorder as the primary diagnosis.
    • If female, must commit to consistent and correct use of an acceptable method of birth control.
    Exclusion criteria:
    • Patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening.
    • Patients with Body Dysmophic Disorder, Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
    • Patients who pose a current suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal.
    • Patients who have a positive urine test at screen for illegal drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months.
    • Patients with an unstable medical disorder.
    • Female patients who are pregnant, lactating, or planning to become pregnant during a specified time during the study.
    • Patients who are taking other psychoactive medications.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Buenos Aires, Buenos Aires, Argentina, C1122AAN
    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
    Ciudad Autonoma de Buenos Aires, Argentina, C1062ABF
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    New York, New York, United States, 10021
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oakbrook Terrace, Illinois, United States, 60181
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73104
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 27 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2006-28-09
    Actual study completion date
    2006-28-09

    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

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