Last updated: 11/07/2018 07:12:27
Special Drug Use Investigation for PAXIL (paroxetine) Social Anxiety Disorder (Long-term)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for PAXIL (paroxetine) Social Anxiety Disorder (Long-term)
Trial description: The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: Paroxetine
Enrollment:
600
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Other
Clinical publications:
Yoshinori Watanabe, Takeshi Kimura, Takeshi Ebihara, Terufumi Hara.Safety and effectiveness in long-term treatment of paroxetine hydrochloride hydrate (Paxil?R tablets) in patients with social anxiety disorder: Findings from special drug use investigation.Jpn Pharmacol Ther.2015;43(5):655-666
Medical condition
Social Phobia
Product
paroxetine
Collaborators
Not applicable
Study date(s)
January 2010 to September 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Subjects who are diagnosed as having SAD
- Subjects who are expected to use paroxetine tablets for the first time
- Subjects taking pimozide
- Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who are diagnosed as having SAD
- Subjects who are expected to use paroxetine tablets for the first time
Exclusion criteria:
- Subjects taking pimozide
- Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor
- Subjects with hypersensitivity to paroxetine
Trial location(s)
No location data available.
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
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2013-30-09
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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