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

Panic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376128
• Other study ID #: 112309
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: May 19, 2017
• Start date: March 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2009
• Est. primary completion date: February 2009
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Panic Disorder

Intervention

Drug:
• Paroxetine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		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
Primary	Efficacy evaluation based on overall improvement		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