NCT00103727已完成2 期
A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy and Safety of a Fixed-Dose of Talnetant Versus Placebo Versus Risperidone in Subjects With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
研究概览
简要总结
This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks and will then return for a follow-up visit 2 weeks later. About 275 patients with schizophrenia will be enrolled in this study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
talnetant
Experimental
200mg, 400mg, 600mg) twice a day
干预措施: Talnetant (Drug)
placebo
Placebo Comparator
placebo
干预措施: placebo (Other)
risperidone
Active Comparator
3mg twice a day
干预措施: risperidone (Other)
结局指标
主要结局
The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
时间窗: 6 weeks
次要结局
- The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).(6 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic PatientsSchizophreniaNCT00300963GlaxoSmithKline275
已完成
2 期
Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)Irritable ColonNCT00101985GlaxoSmithKline741
已完成
2 期
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch PollenAllergic RhinitisNCT02943720Anergis421
已完成
2 期
A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/HydrochlorothiazideHypertensionNCT02222480Boryung Pharmaceutical Co., Ltd103
已完成
3 期
A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic WomenOsteoporosis, PostmenopausalNCT00959764Tarsa Therapeutics, Inc.565