A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Intramuscular ziprasidone mesylate (Drug); Intramuscular haloperidol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
This local registration study is to confirm the hypothesis of the efficacy, tolerability and
safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in
schizophrenia
Clinical Details
Official title: A Randomized, Open Label, Rater Blind, Flexible Dose Multi-Center Study Comparing The Efficacy And Safety Of Intramuscular Ziprasidone With Haloperidol For Three Days In Patients With Agitation Of Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours
Secondary outcome: BPRS Agitation Subscale Response at 72 HoursChange From Baseline in BPRS Agitation Subscale Score at 72 Hours Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female Chinese subjects aged 18-65 years (including 65) at screening.
- Subjects meeting the ICD-10 (Classification of Mental and Behavioral Disorders)
criteria for schizophrenia (F20. X).
- Subjects who are in acute phase of schizophrenia and are appropriate to receive
intramuscular medication for at least 3 days
Exclusion Criteria:
- History of clinically significant physical illness especially myocardial infarction,
non compensatory heart failure etc.
- Subjects receiving an investigational agent in the previous 3 months prior to
screening.
- Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4
hours prior to randomization and during the study.
Locations and Contacts
Pfizer Investigational Site, Beijing 100083, China
Pfizer Investigational Site, Beijing 100088, China
Pfizer Investigational Site, Chang Sha 410011, China
Pfizer Investigational Site, Guangzhou 510370, China
Pfizer Investigational Site, Nanjing 210029, China
Pfizer Investigational Site, Xi'an, China
Pfizer Investigational Site, Baoding, Hebei 071000, China
Pfizer Investigational Site, Wuhan, Hubei 430060, China
Pfizer Investigational Site, Kunming, Yunnan 650032, China
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2008
Last updated: June 30, 2015
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