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

NCT00570063 | Terminated Phase 2 Results

• 1 other identifier: A8241006
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; acute exacerbation; and PF-02545920

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score

  PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). PANSS total score is the sum of the 30 items and ranges from 30 to 210; where higher score indicates greater severity of symptoms.

  Baseline (Day 1), Day 21

Secondary Outcomes (13)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score

  Baseline (Day 1), Day 21

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score

  Baseline (Day 1), Day 21

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score

  Baseline (Day 1), Day 21

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score

  Baseline (Day 1), Day 21

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score

  Baseline (Day 1), Day 21

Other Outcomes (16)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline (Day 1) up to Day 31

• Number of Participants With Vital Signs of Potential Clinical Concern

  Baseline (Day 1) up to Day 31

• Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities

  Baseline (Day 1) up to Day 31

Study Arms (2)

1

PLACEBO COMPARATOR

PF-02545920 15 mg tablets taken twice a day by mouth for 21 days

Drug: PF-02545920

2

PLACEBO COMPARATOR

Matching placebo tablets taken twice a day by mouth for 21 days

Drug: Placebo

Interventions

PF-02545920 DRUG

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

1

Placebo DRUG

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.

2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Evidence or history of clinically significant medical problems.
• Females of childbearing potential.
• A primary psychiatric diagnosis other than schizophrenia.
• A diagnosis of substance abuse or dependence in the last 6 months.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

California Clinical Trials Medical Group, Inc.

Glendale, California, 91206, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Telecare-Cresta Loma

Lemon Grove, California, 91945, United States

Location

California Clinical Trials Medical Group

Paramount, California, 90723, United States

Location

LaPaz Geropsychiatric Center

Paramount, California, 90723, United States

Location

California Clinical Trials Medical Group

San Diego, California, 92123, United States

Location

Connecticut Mental Health Center-Yale University, Clinical Neuroscience Research Unit

New Haven, Connecticut, 06519, United States

Location

CRI Worldwide, LLC

Willingboro, New Jersey, 08046, United States

Location

St. Anthony Hospital

Oklahoma City, Oklahoma, 73101, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Schizophrenia

Interventions

2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinoline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

Due to early termination of the study, PK parameters were not analyzed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 10, 2007
• Study Start: November 1, 2007
• Primary Completion: February 18, 2008
• Study Completion: February 18, 2008
• Last Updated: December 20, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-11

Locations

US (10)