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Drug Use Investigation of Jzoloft.

Last updated on December 7, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Panic Disorder, Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients need to be taking Sertraline hydrochloride in order to be enrolled in the
surveillance.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Patients not taking Sertraline hydrochloride.

NCT00605865
Pfizer
Completed
Drug Use Investigation of Jzoloft.

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Descriptive Information
Brief TitleDrug Use Investigation of Jzoloft.
Official TitleDrug Use Investigation of Jzoloft.
Brief SummaryThe 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.
Detailed DescriptionAll 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients to whom an investigator involved in A0501090 prescribes sertraline hydrochloride.
Condition
  • Panic Disorder
  • Depression
InterventionDrug: Sertraline hydrochloride

J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan.

Dosage, Frequency: According to Japanese LPD, "The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms".

Duration: According to the protocol of A0501090, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 16 weeks after the first administration.

Other Name: J Zoloft, Zoloft
Study Groups/CohortsSertraline hydrochloride.
Patients taking Sertraline hydrochloride.
Intervention: Drug: Sertraline hydrochloride
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: October 10, 2011)
2272
Original Estimated Enrollment
 (submitted: January 30, 2008)
2000
Actual Study Completion DateSeptember 2011
Actual Primary Completion DateSeptember 2011   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00605865
Other Study ID NumbersA0501090
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2012

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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