Special Investigation of Long Term Use of Sertraline. - Tabular View

Tracking Information

First Received Date ^ICMJE

January 18, 2008

Last Updated Date

August 14, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The incidence of adverse drug reactions. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions). [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

The incidence of adverse drug reactions. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00605813 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

This study is a non-interventional/observational study and does not have any secondary outcomes measures. [ Time Frame: There are no secondary outcomes for this study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Special Investigation of Long Term Use of Sertraline.

Official Title ^ICMJE

Special Investigation of Long Term Use of J ZOLOFT.

Brief Summary

Special investigation of long term use of SERTRALINE, 52Week Observation, Long-Term Safety.

The objective of this "Special investigation" 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 regarding to long time use.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Depression
Panic Disorder

Intervention ^ICMJE

Drug: Sertraline hydrochloride

Study Arms / Comparison Groups

Patients taking Sertraline hydrochloride.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

November 2010

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

The patients who take Sertraline hydrochloride for longer than the duration of 16 weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).

Exclusion Criteria:

Patients not taking Sertraline hydrochloride.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00605813

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

A0501091

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP