NCT00570063终止2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 35
- 试验地点
- 9
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1
Placebo Comparator
PF-02545920 15 mg tablets taken twice a day by mouth for 21 days
干预措施: PF-02545920 (Drug)
2
Placebo Comparator
Matching placebo tablets taken twice a day by mouth for 21 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score
时间窗: 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.
次要结局
- Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21(Baseline (Day 1), Day 21)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score(Baseline (Day 1), Day 21)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score(Baseline (Day 1), Day 21)
- 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: 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)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score(Baseline (Day 1), Day 21)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total 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 Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21(Baseline (Day 4), Day 21)
- Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21(Baseline (Day 1), Day 21)
- Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21(Baseline (Day 1), Day 21)
研究者
研究点 (9)
Loading locations...
相似试验
已完成
2 期
A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid ArthritisRheumatoid ArthritisNCT00938587Pfizer86
已完成
2 期
Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic DermatitisAtopic DermatitisNCT05432596Aclaris Therapeutics, Inc.250
已完成
2 期
Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to MethotrexateRheumatoid ArthritisNCT04038970Jiangsu Alphamab Biopharmaceuticals Co., Ltd145
已完成
2 期
Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisNCT01225211Vertex Pharmaceuticals Incorporated312
已完成
2 期
Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular DegenerationAge-related Macular DegenerationChoroidal NeovascularizationNCT02358889Iconic Therapeutics, Inc.88