Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Phase 2, Multicenter, Double-Blind, Randomized, Fixed Dose, Parallel Group, 3-Week Inpatient Treatment Study To Evaluate The Dose-Response Relationship, Safety, Efficacy, And Pharmacokinetics Of PF-00217830 Compared With Placebo, Using Aripiprazole As A Positive Control, In The Treatment Of Acute Exacerbation Of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580125
• Other study ID #: A7251006
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: April 16, 2012
• Start date: November 2007
• Est. completion date: September 2008

Study information

• Verified date: January 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Key inclusion criteria include:

• Have a current diagnosis of schizophrenia.

• Increase in symptoms over the past 2-4 weeks.

• Willing to remain inpatients for the duration of the trial.

Exclusion Criteria:

• Subjects with a current DSM-IV axis I diagnosis other than schizophrenia

• Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence

• Subjects with a history of treatment resistant schizophrenia

• Females of childbearing potential

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• PF-00217830
PF-00217830 5 mg, oral capsule, once daily for 21 days

Other:
• Placebo
Placebo, oral capsule, once daily for 21 days

Drug:
• Aripiprazole
Aripiprazole 15 mg, oral capsule, once daily for 21 days
• PF-00217830
PF-00217830 15 mg, oral capsule, once daily for 21 days
• PF-00217830
PF-00217830 2 mg, oral capsule, once daily for 21 days

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Mangalore	Karnataka
India	Pfizer Investigational Site	Pune	Maharashtra
India	Pfizer Investigational Site	Pune
India	Pfizer Investigational Site	Udupi	Karnataka
Russian Federation	Pfizer Investigational Site	Gatchina district	Leningrad region
Russian Federation	Pfizer Investigational Site	Khotkovo
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	St Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Donetsk
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kiev
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Lugansk
Ukraine	Pfizer Investigational Site	Simferopol	Crimea
United States	Pfizer Investigational Site	Bridgeton	Missouri
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Florissant	Missouri
United States	Pfizer Investigational Site	Garden Grove	California
United States	Pfizer Investigational Site	St. Charles	Missouri
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  India,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).		5 weeks	No
Primary	Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).		5 weeks	No
Primary	Positive and Negative Symptom Scale (PANSS) total score.		Screening, Day 1, 3, 7, 14 and 21	No
Primary	Adverse events (Daily), weight (Screening, Days 1, and 21) and girth (Days 1 and 21), vital signs (Screening, Days 1, 3, 7, 14, 21 and Followup),		5 weeks	No
Primary	Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).		4 weeks	No
Secondary	PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)		Screening, Day 1, 3, 7, 14 and 21	No
Secondary	PANSS positive, negative, and general psychopathology subscales		Screening, Day 1, 3, 7, 14 and 21	No
Secondary	Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)		Screening and Days 1, 3, 7, 14 and 21	No
Secondary	NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF.		Days 1 and 21	No
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM)		Day 21	No
Secondary	Pharmacokinetics		Days 7, 14, 20, 21, before discharge and Followup	No
Secondary	PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content)		Screening and Days 1, 3, 7, 14 and 21	No

External Links

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