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

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ClinicalTrials.gov Identifier: NCT01376128
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment
Panic Disorder Drug: Paroxetine

Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)
Study Start Date : March 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : May 2009


Group/Cohort Intervention/treatment
Subjects prescribed PAXIL
Pediatric subjects with panic disorder prescribed PAXIL during study period
Drug: Paroxetine



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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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

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376128     History of Changes
Other Study ID Numbers: 112309
First Posted: June 20, 2011    Key Record Dates
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