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Trial record 1 of 1 for:    NCT00605917
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Special Investigation Of J Zoloft For Panic Disorder Patients

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ClinicalTrials.gov Identifier: NCT00605917
Recruitment Status : Completed
First Posted : January 31, 2008
Results First Posted : September 21, 2012
Last Update Posted : September 21, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date January 18, 2008
First Posted Date January 31, 2008
Results First Submitted Date August 20, 2012
Results First Posted Date September 21, 2012
Last Update Posted Date September 21, 2012
Study Start Date April 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2012)
  • Number of Participants of Treatment Related Adverse Events (TRAEs) [ Time Frame: Baseline up to 52 weeks ]
    All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
  • Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert [ Time Frame: Baseline up to 52 weeks ]
Original Primary Outcome Measures
 (submitted: January 30, 2008)
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 16 weeks ]
  • The incidence of adverse drug reactions. [ Time Frame: 16 weeks ]
  • The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions). [ Time Frame: 16 weeks ]
Change History Complete list of historical versions of study NCT00605917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 20, 2012)
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without past medical history of other illness is significant risk factor
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)
  • Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor
  • Factors Considered to Affect the Efficacy of Sertraline: Complication [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with responders of Sertraline to determine whether with or without complication is significant factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)
  • Factors Considered to Affect the Efficacy of Sertraline: Drinking Status [ Time Frame: Baseline up to 52 weeks ]
    Number of participants with responders of Sertraline to determine whether drinking status is significant factor
Original Secondary Outcome Measures
 (submitted: January 30, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Investigation Of J Zoloft For Panic Disorder Patients
Official Title Special Investigation Of J Zoloft For Panic Disorder Patients
Brief 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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients to whom an investigator involved in A0501092 prescribes sertraline hydrochloride.
Condition Panic Disorder
Intervention Drug: 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 A0501092, the duration of the investigation for findings regarding safety and efficacy of a panic disorder patient is from the first drug administration to the 16 weeks after the first administration.

Other Name: J Zoloft, Zoloft
Study Groups/Cohorts Sertraline hydrochloride.
The patients of Panic disorder 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 Status Completed
Actual Enrollment
 (submitted: October 10, 2011)
997
Original Estimated Enrollment
 (submitted: January 30, 2008)
1000
Actual Study Completion Date September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00605917
Other Study ID Numbers A0501092
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2012