Drug Use Investigation for PAXIL Tablet
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mental Disorders
Intervention: Paroxetine (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: Drug Use Investigation for PAXIL Tablet
Study design: Time Perspective: Prospective
Primary outcome: Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practicePresence/absence of concomitant use of drugs metabolized by CYP2D6 Presence/absence of concomitant use of products containing Saint John's Wort (Hypericum perforatum; "SJW", hereinafter)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: April 2001
Last updated: June 9, 2011
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