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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-00217830
Placebo
Aripiprazole
PF-00217830
PF-00217830
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Experimental

Experimental

Arm Label

A2

A5

A4

A3

A1

Arm Description

Outcomes

Primary Outcome Measures

Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).
Positive and Negative Symptom Scale (PANSS) total score.
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),
Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).

Secondary Outcome Measures

PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)
PANSS positive, negative, and general psychopathology subscales
Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)
NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF.
Treatment Satisfaction Questionnaire for Medication (TSQM)
Pharmacokinetics
PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content)

Full Information

First Posted
December 20, 2007
Last Updated
April 16, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00580125
Brief Title
Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A2
Arm Type
Experimental
Arm Title
A5
Arm Type
Placebo Comparator
Arm Title
A4
Arm Type
Active Comparator
Arm Title
A3
Arm Type
Experimental
Arm Title
A1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-00217830
Intervention Description
PF-00217830 5 mg, oral capsule, once daily for 21 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo, oral capsule, once daily for 21 days
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Aripiprazole 15 mg, oral capsule, once daily for 21 days
Intervention Type
Drug
Intervention Name(s)
PF-00217830
Intervention Description
PF-00217830 15 mg, oral capsule, once daily for 21 days
Intervention Type
Drug
Intervention Name(s)
PF-00217830
Intervention Description
PF-00217830 2 mg, oral capsule, once daily for 21 days
Primary Outcome Measure Information:
Title
Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
Time Frame
5 weeks
Title
Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).
Time Frame
5 weeks
Title
Positive and Negative Symptom Scale (PANSS) total score.
Time Frame
Screening, Day 1, 3, 7, 14 and 21
Title
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),
Time Frame
5 weeks
Title
Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)
Time Frame
Screening, Day 1, 3, 7, 14 and 21
Title
PANSS positive, negative, and general psychopathology subscales
Time Frame
Screening, Day 1, 3, 7, 14 and 21
Title
Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)
Time Frame
Screening and Days 1, 3, 7, 14 and 21
Title
NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF.
Time Frame
Days 1 and 21
Title
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame
Day 21
Title
Pharmacokinetics
Time Frame
Days 7, 14, 20, 21, before discharge and Followup
Title
PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content)
Time Frame
Screening and Days 1, 3, 7, 14 and 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pfizer Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Pfizer Investigational Site
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044-2588
Country
United States
Facility Name
Pfizer Investigational Site
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63033
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Pfizer Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Facility Name
Pfizer Investigational Site
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India
Facility Name
Pfizer Investigational Site
City
Udupi
State/Province
Karnataka
ZIP/Postal Code
576 102
Country
India
Facility Name
Pfizer Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
Pfizer Investigational Site
City
Pune
ZIP/Postal Code
411 030
Country
India
Facility Name
Pfizer Investigational Site
City
Gatchina district
State/Province
Leningrad region
ZIP/Postal Code
188357
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Khotkovo
ZIP/Postal Code
141371
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
194214
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Simferopol
State/Province
Crimea
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49115
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Donetsk
ZIP/Postal Code
83037
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kiev
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7251006&StudyName=Dose-response%20study%20to%20evaluate%20safety%2C%20efficacy%2C%20and%20pharmacokinetics%20of%20PF-00217830%20compared%20with%20placebo%20in%20acute%20exacerbation%20of%20sch
Description
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Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia

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