Last updated: 11/03/2018 12:49:26
Drug Use Investigation for PAXIL Tablet
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation for PAXIL Tablet
Trial description: This post-marketing surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
Timeframe: 8 weeks
Presence/absence of concomitant use of drugs metabolized by CYP2D6
Timeframe: Within 2 weeks after discontinuation or completion of treatment
Presence/absence of concomitant use of products containing Saint John’s Wort (Hypericum perforatum; “SJW”, hereinafter)
Timeframe: 8 weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: Paroxetine
Enrollment:
3708
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Mental Disorders
Product
paroxetine
Collaborators
Not applicable
Study date(s)
April 2001 to December 2005
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
None
- Patients with depression/depressed state or panic disorder
- Patients who had been taking PAXIL since before the start of the survey
- Patients with hypersensitivity to paroxetine
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with depression/depressed state or panic disorder
Exclusion criteria:
- Patients who had been taking PAXIL since before the start of the survey
- Patients with hypersensitivity to paroxetine
- Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
- Concomitant use in patients taking pimozide
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
2005-01-12
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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