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

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ClinicalTrials.gov Identifier: NCT00570063
Recruitment Status : Terminated
First Posted : December 10, 2007
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 6, 2007
First Posted Date  ICMJE December 10, 2007
Results First Submitted Date  ICMJE November 20, 2017
Results First Posted Date  ICMJE December 20, 2017
Last Update Posted Date December 20, 2017
Actual Study Start Date  ICMJE November 2007
Actual Primary Completion Date February 18, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score [ Time Frame: Baseline (Day 1), Day 21 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
  • Change from baseline to endpoint on the Positive and Negative Symptom Assessment Scale (PANSS). [ Time Frame: 3 weeks ]
  • Safety and tolerability [ Time Frame: 3 weeks ]
Change History Complete list of historical versions of study NCT00570063 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score [ Time Frame: Baseline (Day 1), Day 21 ]
    PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS positive subscale assesses the positive symptoms associated with schizophrenia as delusions, conceptual disorganization, and hallucinatory behavior. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive subscale is the sum of 7 items and ranges from 7 to 49; where higher score indicates greater severity of symptoms.
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score [ Time Frame: Baseline (Day 1), Day 21 ]
    PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS negative subscale assesses negative symptoms associated with schizophrenia as blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative subscale score is the sum of 7 items and ranges from 7 to 49, where higher score indicates greater severity of symptoms.
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score [ Time Frame: Baseline (Day 1), Day 21 ]
    PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS general psychopathology subscale score assesses general psychopathology symptoms associated with schizophrenia as somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. It consists of 16 items and each item is rated on a scale from 1 (symptoms absent) to 7 (extreme psychopathology). PANSS general psychopathology subscale score is the sum of 16 items and ranges from 16 to 112; where higher scores indicates greater severity of symptoms.
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score [ Time Frame: Baseline (Day 1), Day 21 ]
    PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS positive Marder factor score consists of 8 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive Marder factor score is the sum of 8 items and ranges from 8 to 56; where higher score indicating greater severity of symptoms.
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score [ Time Frame: Baseline (Day 1), Day 21 ]
    PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS negative Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score [ Time Frame: Baseline (Day 1), Day 21 ]
    PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS disorganized thought Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS disorganized thought Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score [ Time Frame: Baseline (Day 1), Day 21 ]
    PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS hostility/excitement Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS hostility/excitement Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score [ Time Frame: Baseline (Day 1), Day 21 ]
    PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS anxiety/depression Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS anxiety/depression Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score [ Time Frame: Baseline (Day 1), Day 21 ]
    BPRS is a clinician-rated instrument for assessing conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content associated with schizophrenia. The scale consists of 18 items. Each item is rated on a scale from 0 (symptom not present) to 6 (symptoms extremely severe). BPRS core psychosis total score is the sum of 18 items and ranges from 0 to 108; where higher score indicates greater severity of symptoms.
  • Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21 [ Time Frame: Baseline (Day 1), Day 21 ]
    CGI-S is a 7-point clinician-rated scale for assessing the global severity of schizophrenia. Score range: 1 (normal - not ill at all) to 7 (most extreme illness). Higher score indicating greater degree of illness.
  • Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21 [ Time Frame: Baseline (Day 4), Day 21 ]
    CGI-improvement is a 7-point clinician-rated scale for assessing the global improvement of schizophrenia ranging from 1 (very much improved) to 7 (very much worse). Higher score indicating less improvement.
  • Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 [ Time Frame: Baseline (Day 1), Day 21 ]
    NOSIE is an inpatient treatment staff-administered questionnaire. It consists of 30 items: 26 items divided into 6 subscales and 4 individual items. Each item is rated on a 5-point scale (0= never to 4= always), to assess functional ability of participants. 6 subscales: irritability (sum of 5 items: score range 0 to 20), manifest psychosis (sum of 4 items: score range 0 to 16), personal neatness (sum of 4 items: score range 0 to 16), retardation (sum of 3 items: score range 0 to 12), social competence (sum of 5 items: score range 0 to 20) and social interest (sum of 5 items: score range 0 to 20) and 4 individual items: cried (score range 0 to 4), refused to speak (score range 0 to 4), said felt blue or depressed (score range 0 to 4) and said he/she was no good (score range 0 to 4). For each of the 6 subscales and 4 individual items: higher scores indicates irregular functional ability.
  • Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21 [ Time Frame: Baseline (Day 1), Day 21 ]
    GAF is a single clinician-rated item to measure the severity of illness-related impairment in psychological, social and occupational functioning. It is a 100 point rating scale, score range: 0= worst functioning to 99= superior functioning, where higher scores indicates better functioning.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
  • Change from baseline to endpoint on the PANSS subscales (positive, negative and general psychopathology [ Time Frame: 3 weeks ]
  • Changes on the Clinical global impression scales (Severity and Improvement) [ Time Frame: 3 weeks ]
  • Pharmacokinetic parameters (how the body handles the drug) [ Time Frame: 3 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: November 20, 2017)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Day 1) up to Day 31 ]
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
  • Number of Participants With Vital Signs of Potential Clinical Concern [ Time Frame: Baseline (Day 1) up to Day 31 ]
    Criteria for vital signs of potential clinical concern: pulse rate (supine/sitting position) less than (<) 40 or greater than (>) 120 beats per minute (bpm), pulse rate in standing position <40 or >140 bpm; systolic blood pressure (SBP) <90 millimeters of mercury (mm Hg) and greater than or equal to (>=) 30 mm Hg change (increase, decrease) from baseline in same posture; diastolic blood pressure (DBP) <50 mm Hg and >=20 mm Hg change (increase, decrease) from baseline in same posture.
  • Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities [ Time Frame: Baseline (Day 1) up to Day 31 ]
    Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal and neurological systems. Clinical significance was based on the investigator's discretion.
  • Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern [ Time Frame: Baseline (Day 1) up to Day 31 ]
    Criteria for ECG values for potential clinical concern: PR interval >=300 millisecond (msec), >=25 percent increase when baseline >200 msec, and >=50 percent increase when baseline less than or equal to (<=) 200 msec; QRS interval >=200 msec, >=25 percent increase when baseline >100 msec, and >=50 percent increase when baseline <=100 msec; QTcB interval (corrected QT interval using Bazett's formula) >=500 msec.
  • Number of Participants With Laboratory Abnormalities [ Time Frame: Baseline (Day 1) up to Day 31 ]
    Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell (RBC) count: <0.8*lower limit of normal (LLN), platelet: <0.5*LLN or >1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN or >1.5*ULN, lymphocyte, neutrophil: <0.8*LLN or >1.2*ULN, basophil, eosinophil, monocyte: >1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase: > 3.0*ULN, total protein, albumin: <0.8*LLN or>1.2*ULN; blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; cholesterol (HDL <0.8*LLN, LDL >1.2*ULN); sodium <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN or >1.1*ULN, phosphate <0.8*LLN or >1.2*ULN; prolactin >1.1*ULN; glucose <0.6*LLN or >1.5*ULN, glycosylated hemoglobin >1.3*ULN, creatine kinase >2.0*ULN; urine (pH <4.5 or >8, glucose, ketone, protein, blood/Hgb >=1, RBC, WBC >=6).
  • Number of Participants With Abnormal Prolactin Level [ Time Frame: Baseline (Day 1) up to Day 21 ]
    Number of participants with abnormal values (>1.1* ULN) of prolactin level were reported.
  • Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level [ Time Frame: Baseline up to Day 21 ]
    Number of participants with abnormal values of HDL level <0.8* LLN and LDL level >1.2*ULN were reported.
  • Number of Participants With Abnormal Glycosylated Hemoglobin (HbA1c) Level [ Time Frame: Baseline (Day 1) up to Day 21 ]
    Number of participants with abnormal values (>1.3* ULN) of HbA1c level were reported.
  • Number of Participants With Abnormal Fasting Insulin Level [ Time Frame: Baseline (Day 1) up to Day 21 ]
    Fasting glucose level below 6 micro international unit per milliliter (mcIU/mL) or above 27 mcIU/mL were considered as abnormal. Number of participants with abnormal values of fasting insulin level were reported.
  • Change From Baseline in Body Weight at Day 21 [ Time Frame: Baseline (Day 1), Day 21 ]
  • Change From Baseline in Abdominal Girth at Day 21 [ Time Frame: Baseline (Day 1), Day 21 ]
  • Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 [ Time Frame: Baseline (Day 1), Day 21 ]
    ESRS-A is an instrument used to assess extrapyramidal symptoms (including tremor and dystonic reactions). It assesses 4 items: Parkinsonism, dystonia, dyskinesia, and akathisia. Each item is scored on a 5-point severity scale ranging from 0 to 4, with higher score indicating greater severity of symptoms.
  • Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 [ Time Frame: Baseline (Day 1), Day 4, 7, 14, 21 ]
    SSS is a 7-point Likert scale which facilitates standardized observation of alertness and rates sleepiness, where 1= alert/wide awake, 2= able to concentrate, 3= not at full alertness, 4= not at peak and let down, 5= beginning to lose interest in remaining awake, 6= sleepiness, 7= sleep onset soon; lost struggle to remain awake. Score ranging from 1 to 7, where higher score indicates more sleepiness.
  • Oral Clearance (CL/F) of PF-02545920 [ Time Frame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
  • Area Under the Concentration Time Curve (AUC) of PF-02545920 [ Time Frame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21 ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
  • Steady State Average Concentration of PF-02545920 Over the Dosing Interval (Css,Avg) [ Time Frame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: 1
    PF-02545920 15 mg tablets taken twice a day by mouth for 21 days
    Intervention: Drug: PF-02545920
  • Placebo Comparator: 2
    Matching placebo tablets taken twice a day by mouth for 21 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 9, 2008)
35
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2007)
54
Actual Study Completion Date  ICMJE February 18, 2008
Actual Primary Completion Date February 18, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00570063
Other Study ID Numbers  ICMJE A8241006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP