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
  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:


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   (Child)
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

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:
Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 27, 2016