Last updated: 11/03/2018 12:49:37

Special Drug Use Investigation for PAXIL Tablet (Long-term)

GSK study ID
112302
See study documents
Clinicaltrials.gov ID
NCT01371448
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 Tablet (Long-term)
Trial description: This surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine in long-term use (1 year).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice

Timeframe: 1 year

Presence/absence of concomitant use of drugs metabolized by CYP2D6

Timeframe: Within 2 weeks after discontinuation or completion of treatment

Presence/absence of concomitant use of products containing Saint John’s Wort (Hypericum perforatum; “SJW”, hereinafter)

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Paroxetine
    • Enrollment:
    339
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Mental Disorders
    Product
    paroxetine
    Collaborators
    Not applicable
    Study date(s)
    May 2001 to September 2005
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    None
    • Patients with depression/depressed state or panic disorder
    • PAXIL must be used for long-term
    • Patients who had been taking PAXIL since before the start of the survey
    • Patients with hypersensitivity to paroxetine
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with depression/depressed state or panic disorder
    • PAXIL must be used for long-term
    Exclusion criteria:
    • Patients who had been taking PAXIL since before the start of the survey
    • Patients with hypersensitivity to paroxetine
    • Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
    • Concomitant use in patients taking pimozide

    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
    2005-30-09

    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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