A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01053429
First received: January 19, 2010
Last updated: December 21, 2010
Last verified: December 2010
  Purpose

This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy) signals will be checked at every visit during the contracted study period until the maximum study end date, per the protocol, of April 2010.


Condition Intervention
Bipolar Disorder
Schizophrenia
Drug: ziprasidone

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance (PMS) Study to Evaluate Safety and Efficacy of Zeldox Capsule

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population [ Time Frame: Baseline up to Week 8 ] [ Designated as safety issue: No ]
    CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.

  • Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population [ Time Frame: Baseline up to Week 8 ] [ Designated as safety issue: No ]
    CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.

  • Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT [ Time Frame: Baseline up to Week 8 ] [ Designated as safety issue: No ]
    CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.

  • Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP [ Time Frame: Baseline up to Week 8 ] [ Designated as safety issue: No ]
    CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.


Enrollment: 3391
Study Start Date: June 2005
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
observational cohort Drug: ziprasidone
This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.
Other Name: Geodon, Zeldox

Detailed Description:

All patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.

Criteria

Inclusion Criteria:

  • Patients diagnosed with schizophrenia

Exclusion Criteria:

  • Patients who have known hypersensitivity to any ingredient of the product
  • Patients who have had a recent acute myocardial infarction
  • Patients who have uncompensated heart failure
  • Patients who have conditions with a potential to increase QT interval (QT-interval prolongation or history of QT prolongation; congenital long QT syndrome; use with other drugs known to increase the QT interval; arrhythmias treated with class I and III antiarrhythmic drugs)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053429

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01053429     History of Changes
Other Study ID Numbers: A1281140
Study First Received: January 19, 2010
Results First Received: December 21, 2010
Last Updated: December 21, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Pfizer:
Regulatory Post-Marketing Surveillance
Regulatory Pharmacovigilance
ziprasidone

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 27, 2014