Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)

NCT ID: NCT01376128

Last Updated: 2017-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-05-31

Brief Summary

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The objectives of this survey was to retrospectively collect and evaluate the information on the efficacy and safety of PAXIL tablets ("PAXIL", hereinafter) in pediatric subjects (aged under 18) with panic disorder under conditions of actual use.

Detailed Description

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Conditions

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Panic Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects prescribed PAXIL

Pediatric subjects with panic disorder prescribed PAXIL during study period

Paroxetine

Intervention Type DRUG

Interventions

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Paroxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged under 18 at the time of the panic disorder diagnosis
* Aged under 18 on the starting day of PAXIL treatment
* Having been making periodic visits to the hospital to receive treatment for panic disorder

Exclusion Criteria

* Subjects who have been treated with paroxetine prior to this investigation
* Subjects with hypersensitivity to paroxetine
* Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in patients taking pimozide
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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112309

Identifier Type: -

Identifier Source: org_study_id

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