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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 practice

Presence/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

Page last updated: August 23, 2015

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