Last updated: 11/07/2018 04:40:56
Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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
Timeframe: 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
Timeframe: 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
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
96
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Atsuko Ishida, Terufumi Hara, Ryoko Sato. Report of Results of a Retrospective Study Aimed at Assessing Safety and Efficacy of Paroxetine Hydrochloride Hydrate Tablets (Paxil® Tablets) for Patients with Panic Disorder (Aged<18 Years) ~ Special Drug Use Investigation ~. Rinsho seishin igaku. 2013;42(7):909-919.
Medical condition
Panic Disorder
Product
paroxetine
Collaborators
Not applicable
Study date(s)
March 2008 to May 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable N/A - 17 years
Accepts healthy volunteers
None
- Aged under 18 at the time of the panic disorder diagnosis
- Aged under 18 on the starting day of PAXIL treatment
- Subjects who have been treated with paroxetine prior to this investigation
- Subjects with hypersensitivity to paroxetine
Inclusion and exclusion 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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2009-11-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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