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

NCT01376128 | Completed

• 1 other identifier: 112309
• Study Type: observational
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Subjects prescribed PAXIL

Pediatric subjects with panic disorder prescribed PAXIL during study period

Drug: Paroxetine

Interventions

Paroxetine DRUG

Subjects prescribed PAXIL

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Panic Disorder

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 20, 2011
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 22, 2017

Record last verified: 2017-05