Drug Use Investigation of Jzoloft.
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00605865
First received: January 18, 2008
Last updated: August 28, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Panic Disorder Depression |
Drug: Sertraline hydrochloride |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Drug Use Investigation of Jzoloft. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants of Treatment Related Adverse Events (TRAEs) [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: Yes ]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 16 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: Yes ]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.)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: Yes ]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: Renal Dysfunction [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: Yes ]Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction 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 16 weeks ] [ Designated as safety issue: Yes ]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: Average Daily Dose [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: Yes ]Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt) [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: Yes ]Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: Yes ]Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor
- Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: No ]Number of participants with responders of Sertraline to determine whether target disease severity is significant factor
- Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: No ]Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor
- Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: No ]Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor
- Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments. [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: No ]Number of participants with responders of Sertraline to determine whether with or without complication is significant factor
- Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: No ]Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor
- Factors Considered to Affect the Efficacy of Sertraline: Age [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: No ]Number of participants with responders of Sertraline to determine whether age is significant factor
- Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt) [ Time Frame: Baseline up to 16 weeks ] [ Designated as safety issue: No ]Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor
| Enrollment: | 2272 |
| Study Start Date: | April 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Sertraline hydrochloride.
Patients taking Sertraline hydrochloride.
|
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 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
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The patients to whom an investigator involved in A0501090 prescribes sertraline hydrochloride.
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00605865 History of Changes |
| Other Study ID Numbers: | A0501090 |
| Study First Received: | January 18, 2008 |
| Results First Received: | August 28, 2012 |
| Last Updated: | August 28, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Panic Disorder Behavioral Symptoms Mood Disorders Mental Disorders Anxiety Disorders Sertraline Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013