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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 Hours

Change 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

Page last updated: August 23, 2015

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