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A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Baoding, Hebei, 071000 China
Contact
1-800-718-1021
ClinicalTrials.go[email protected]
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00723606
Pfizer
Completed
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation

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A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
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
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Intramuscular ziprasidone mesylate
    The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days.
    Other Name: Zeldox, Geodon
  • Drug: Intramuscular haloperidol
    The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.
    Other Name: Haldol
  • Experimental: Intramuscular ziprasidone
    Intervention: Drug: Intramuscular ziprasidone mesylate
  • Active Comparator: Intramuscular haloperidol
    Intervention: Drug: Intramuscular haloperidol
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
376
July 2009
July 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00723606
A1281152
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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