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临床试验/NCT00464061
NCT00464061终止3 期

Efficacy and Safety of 2mg/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

Sanofi2 个研究点 分布在 2 个国家目标入组 1,847 人开始时间: 2007年4月最近更新:
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适应症
干预措施

试验速览

阶段
3 期
状态
终止
发起方
Sanofi
入组人数
1,847
试验地点
2
主要终点
Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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
Double (Participant, Investigator)

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 participant's information related to sleep pattern during the preceding month
  • •Sub-study :
  • •Participants 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 participant's potential participation in a clinical trial.

研究组 & 干预措施

Volinanserin

Experimental

干预措施: Volinanserin (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)

时间窗: at 3 months

Efficacy (sub-study): change from baseline for glycemic measure HbA1c

时间窗: at 6 and 12 months

次要结局

  • Safety: adverse events and laboratory abnormalities(during 12 months of treatment)
  • Efficacy: change from baseline of the pr-WASO(at 6 and 12 months)
  • Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire(at 3 months)

研究者

发起方
Sanofi
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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