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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Panic Disorder

Intervention: Paroxetine (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

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

Study design: Time Perspective: Retrospective

Primary outcome:

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

Efficacy evaluation based on overall improvement

Eligibility

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: March 2008
Last updated: June 16, 2011

Page last updated: August 23, 2015

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