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Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)

Primary Purpose

Social Phobia

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Paroxetine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Social Phobia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who are diagnosed as having SAD
  • Subjects who are expected to use paroxetine tablets for the first time

Exclusion Criteria:

  • Subjects taking pimozide
  • Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor
  • Subjects with hypersensitivity to paroxetine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Arm Label

    Subjects prescribed paroxetine tablets

    Arm Description

    Subjects with SAD prescribed paroxetine tablets during study period

    Outcomes

    Primary Outcome Measures

    The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2011
    Last Updated
    June 30, 2014
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01376271
    Brief Title
    Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)
    Official Title
    Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Social Phobia

    7. Study Design

    Enrollment
    600 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Subjects prescribed paroxetine tablets
    Arm Description
    Subjects with SAD prescribed paroxetine tablets during study period
    Intervention Type
    Drug
    Intervention Name(s)
    Paroxetine
    Primary Outcome Measure Information:
    Title
    The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects who are diagnosed as having SAD Subjects who are expected to use paroxetine tablets for the first time Exclusion Criteria: Subjects taking pimozide Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor Subjects with hypersensitivity to paroxetine
    Study Population Description
    All subjects diagnosed as having social anxiety disorder (SAD) are to be given paroxetine tablets according to the prescribing information
    Sampling Method
    Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)

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