NCT00495885已完成3 期
Efficacy and Safety of 2 mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 848
- 试验地点
- 1
- 主要终点
- change from baseline to 12 weeks for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
研究概览
简要总结
The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria
- •Disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
- •Sub-study :
- •Patients will be included if they have an established medical diagnosis of type II Diabetes Mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening)
排除标准
- •Females who are lactating or who are pregnant
- •Night shift workers, and individuals who nap 3 or more times per week over the preceding month
- •Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
- •Participation in another trial having received study medication within 1 month before the screening visit
- •Body Mass Index ≥ 33
- •Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication
- •Use of any substance with psychotropic effects or properties know to affect sleep/wake
- •History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
- •Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
- •Positive qualitative urine drug screen (opiates, cocaine, amphetamine...)
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Volinanserin
Experimental
Volinanserin 2 mg for a maximum of 87 days
干预措施: volinanserin (M100907) (Drug)
Placebo
Placebo Comparator
Placebo for volinanserin for a maximum of 106 days
干预措施: Placebo (Drug)
结局指标
主要结局
change from baseline to 12 weeks for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
时间窗: 12 weeks
次要结局
- Change from baseline to 12-week of "General Productivity" domain from Functional Outcomes of Sleep Questionnaire (FOSQ).(12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes MellitusSleep Initiation and Maintenance DisordersNCT00464061Sanofi1,847
已完成
3 期
Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic StudySleep Initiation and Maintenance DisordersNCT00464243Sanofi604
进行中（未招募）
不适用
Efficacy and safety of 2 mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a One Year, multi-center, randomized, double-blind, placebo-controlled study - SAMSEUCTR2006-004942-18-ATsanofi-aventis recherche et developpment1,800
进行中（未招募）
不适用
Efficacy and safety of 2 mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a One Year, multi-center, randomized, double-blind, placebo-controlled study - SAMSEUCTR2006-004942-18-DEsanofi-aventis recherche et developpment1,800
进行中（未招募）
不适用
Efficacy and safety of 2 mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a One Year, multi-center, randomized, double-blind, placebo-controlled study - SAMSsleep maintenance insomniaMedDRA version: 9.0Level: LLTClassification code 10022437EUCTR2006-004942-18-BEsanofi-aventis recherche et developpment1,800