Last updated: 11/07/2018 07:12:27

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

GSK study ID
114102
See study documents
Clinicaltrials.gov ID
NCT01376271
EudraCT ID
Not applicable
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: Special Drug Use Investigation for PAXIL (paroxetine) Social Anxiety Disorder (Long-term)
Trial description: The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Paroxetine
    • Enrollment:
    600
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Yoshinori Watanabe, Takeshi Kimura, Takeshi Ebihara, Terufumi Hara.Safety and effectiveness in long-term treatment of paroxetine hydrochloride hydrate (Paxil?R tablets) in patients with social anxiety disorder: Findings from special drug use investigation.Jpn Pharmacol Ther.2015;43(5):655-666
    Medical condition
    Social Phobia
    Product
    paroxetine
    Collaborators
    Not applicable
    Study date(s)
    January 2010 to September 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Subjects who are diagnosed as having SAD
    • Subjects who are expected to use paroxetine tablets for the first time
    • Subjects taking pimozide
    • Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-30-09

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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