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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01376128

First received: June 9, 2011

Last updated: June 16, 2011

Last verified: June 2011

History of Changes

Purpose

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.

Condition	Intervention
Panic Disorder	Drug: Paroxetine


Study Type:	Observational
Study Design:	Time Perspective: Retrospective
Official Title:	Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)

Resource links provided by NLM:

MedlinePlus related topics: Panic Disorder

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 [ Time Frame: From the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years ] [ Designated as safety issue: Yes ]
Efficacy evaluation based on overall improvement [ Time Frame: From the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years ] [ Designated as safety issue: Yes ]


Enrollment:	96
Study Start Date:	March 2008
Study Completion Date:	May 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Subjects prescribed PAXIL Pediatric subjects with panic disorder prescribed PAXIL during study period	Drug: Paroxetine

Eligibility


Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Sampling Method:	Probability Sample

Study Population

Male and female Japanese subjects whose age is under 18 with panic disorder, who are considered appropriate to prescribe paroxetine tablet according to the prescribing information

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376128

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

No publications provided


Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01376128 History of Changes
Other Study ID Numbers:	112309
Study First Received:	June 9, 2011
Last Updated:	June 16, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:


Panic Disorder Anxiety Disorders Mental Disorders

ClinicalTrials.gov processed this record on March 01, 2015

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