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Special Investigation Of J Zoloft For Panic Disorder Patients

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Panic Disorder

Intervention: Sertraline hydrochloride (Drug)

Phase: N/A

Status: Completed

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 for panic disorder patients 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: Special Investigation Of J Zoloft For Panic Disorder Patients

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Number of Participants of Treatment Related Adverse Events (TRAEs)

Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert

Secondary outcome:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications

Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug

Factors Considered to Affect the Efficacy of Sertraline: Complication

Factors Considered to Affect the Efficacy of Sertraline: Drinking Status

Detailed description: All patients with panic disorder to 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 with panic disorder 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
Last updated: August 20, 2012

Page last updated: August 23, 2015

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