NCT00551148已完成2 期
PD 0200390 Dose-ranging Trial: A Randomized, Double-blind, Placebo-controlled, 5-way Crossover, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography
研究概览
简要总结
The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 month history of Primary Insomnia (DSM-IV criteria)
- •Self report sleep criteria for at least 3 nights per week in past month;
- •sWASO (subjective wake after sleep onset) equal or greater than 60 mins
- •sLSO (subjective latency to sleep onset) equal or greater than 45 minutes
- •TST less than or equal to 6.5 hrs
- •Maintain normal daytime-awake, nighttime-sleep schedule
- •PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights
- •TST between 3 to 7 hrs on 2 PSG screening nights
- •Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights
排除标准
- •Comorbid psychiatric disease or disorders
- •History or presence of breathing-related disorders
- •Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening
- •History or presence of medical or neurological condition interfering with sleep
- •Current use of know psychotropic effect medications
- •Excessive caffeine use
- •Use of alcohol as a sleep aid or more than 2 standard drinks/day
研究组 & 干预措施
15 mg
Experimental
干预措施: PD 0200390 (Drug)
30 mg
Experimental
干预措施: PD 0200390 (Drug)
5 mg
Experimental
干预措施: PD 0200390 (Drug)
60 mg
Experimental
干预措施: PD 0200390 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography
时间窗: weekly
次要结局
- Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ.(weekly)
- PSG efficacy assessments including number of awakenings after sleep onset (NAASO), number of arousals, total sleep time (TST), sleep efficiency (SE), total wake time (TWT)(weekly)
- Subjective assessments of wake after sleep onset (sWASO), latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO), total sleep time (TST), and sleep quality via questionnaire.(weekly)
- Latency to persistent sleep (LPS) as determined by Polysomnography(weekly)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary InsomniaInsomniaNCT00569972Pfizer682
已完成
2 期
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer PatientsProstate CancerNCT00196339Duramed Research315
已完成
2 期
Phase 2 Study - Erdosteine in Patients With CB/COPDChronic Obstructive Pulmonary DiseaseChronic BronchitisNCT00338507Adams Respiratory Therapeutics400
已完成
2 期
Dose Ranging Study With LT, Monotherapy, PPARDiabetes Mellitus IINCT00240383Bristol-Myers Squibb1,260
已完成
2 期
A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)MigraineNCT01613248Allergan834