NCT00992160已完成2 期
A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/Day) for the Treatment of Primary Insomnia in Adult Outpatients
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
- 161
- 试验地点
- 1
- 主要终点
- Nocturnal polysomngraphy
研究概览
简要总结
This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders -Text Revision (DSM-IV-TR) criteria 307.42
- •PSG variables collected during 2consecutive PSG screening nights falling as follows: TST between 240-420 mins inclusive (both nights) - LPS (Latency to Persistent Sleep): mean not less than 20mins, each night not less than 15 mins - WASO (Wake After Sleep Onset): mean not less than 60mins, each night not less than 45mins
- •Women: non child bearing potential or if child bearing potential agree on Contraceptive Methods listed in Protocol
排除标准
- •clinically significant Psychiatric and neurological disorders (sleep disorders other than Primary Insomnia, history of alcohol orother substance abuse or dependnce);
- •nightshift or rotating shift-work;
- •Lifestyle habits in agreement with Protocol requirement: caffeine - alcohol intake and smoke
- •healthy according to GSK criteria - laboratory and ECG limits set in the Protocol
研究组 & 干预措施
Active
Experimental
Vestipitant 15mg once daily
干预措施: GW597599 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Nocturnal polysomngraphy
时间窗: 6 weeks after start of treatment
次要结局
- Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index(4 weeks after start of treatment)
- Motor and cognitive functioning assessed by neurological tests (Romberg and Hee-to-toe) and Cognitive tests (Digit Symbol Substitution test and verbal Learning Memory test)(4 weeks after start of treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)NocturiaBenign Prostatic Hypertrophy (BPH)NCT01330927Vantia Ltd30
进行中（未招募）
不适用
A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/day) for the Treatment of Primary Insomnia in Adult Outpatients.Primary Insomnia in Adult OutpatientsMedDRA version: 9.1Level: LLTClassification code 10036701Term: Primary insomniaEUCTR2008-006345-72-DEGlaxoSmithKline Research & Development Ltd152
已完成
2 期
Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary InsomniaSleep Initiation and Maintenance DisordersInsomniaNCT00280423GlaxoSmithKline342
已完成
2 期
Valerian to Improve Sleep in Patients With Parkinson's DiseaseParkinson's DiseaseInsomniaNCT00070928National Center for Complementary and Integrative Health (NCCIH)80
已完成
4 期
Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar DepressionBipolar DepressionNCT00926393AstraZeneca139