We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376128
First Posted: June 20, 2011
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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: Observational Model: Other
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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376128


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376128     History of Changes
Other Study ID Numbers: 112309
First Submitted: June 9, 2011
First Posted: June 20, 2011
Last Update Posted: May 22, 2017
Last Verified: May 2017

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