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Drug Use Investigation of Jzoloft

Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression; Panic Disorder

Intervention: Sertraline hydrochloride (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The objective of this surveillance is to collect information about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

Clinical Details

Official title: Drug Use Investigation of Jzoloft

Study design: Case-Only, Prospective

Primary outcome:

Factors considered to affect the safety and/or efficacy of this drug.

The incidence of adverse drug reactions.

The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions).

Secondary outcome: This study is a non-interventional/observational study and does not have any secondary outcomes measures.

Detailed description: All the patients whom an investigator prescribes the first Sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients need to be taking Sertraline hydrochloride in order to be enrolled in the

surveillance.

Exclusion Criteria:

- Patients not taking Sertraline hydrochloride.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: April 2007
Ending date: November 2010
Last updated: February 4, 2008

Page last updated: June 20, 2008

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