Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo

This study has been terminated.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00570063
First received: December 6, 2007
Last updated: September 25, 2009
Last verified: September 2009
  Purpose

To assess the efficacy and safety of an investigational compound PF-02545920 for the treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing symptoms associated with schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: PF-02545920
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Double Blind, Randomized, Fixed Dose, Parallel Group, 3 Week Inpatient Treatment Study To Evaluate The Safety, Efficacy And Pharmacokinetics Of PF-02545920 Compared With Placebo In The Treatment Of Acute Exacerbation Of Schizophrenia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline to endpoint on the Positive and Negative Symptom Assessment Scale (PANSS). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • ECG and ESRS-A as safety measures of change from baseline to endpoint [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to endpoint on the PANSS subscales (positive, negative and general psychopathology [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Changes on the Clinical global impression scales (Severity and Improvement) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters (how the body handles the drug) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: November 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Matching placebo tablets taken twice a day by mouth for 21 days
Drug: Placebo
Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days.
Placebo Comparator: 1
PF-02545920 15 mg tablets taken twice a day by mouth for 21 days
Drug: PF-02545920
Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a current diagnosis of schizophrenia.
  2. Increase in symptoms over the past 2-4 weeks.
  3. Willing to remain inpatients for the duration of the trial.

Exclusion Criteria:

  1. Evidence or history of clinically significant medical problems.
  2. Females of childbearing potential.
  3. A primary psychiatric diagnosis other than schizophrenia.
  4. A diagnosis of substance abuse or dependence in the last 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570063

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Pfizer Investigational Site
Lemon Grove, California, United States, 91945
Pfizer Investigational Site
Paramount, California, United States, 90723
Pfizer Investigational Site
San Diego, California, United States, 92123
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
United States, New Jersey
Pfizer Investigational Site
Willingboro, New Jersey, United States, 08046
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 93101
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00570063     History of Changes
Other Study ID Numbers: A8241006
Study First Received: December 6, 2007
Last Updated: September 25, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Schizophrenia, acute exacerbation, and PF-02545920

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014