ACTRN12618001579280已完成1 期
The effects of LGT-371 on obstructive sleep apnoea (OSA) severity in men and women with moderate-to-severe OSA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Otherwise healthy men and women with moderate-to-severe obstructive sleep apnoea
排除标准
- •Medical and concurrent medication exclusions in accordance with the most recently published Summary of Product Characteristics (SPC) for LGT-371
- •Concurrent or recent (within the past month) use of any medication known to influence sleep, arousal, circadian rhythm, breathing or muscle function
- •For women: Pregnancy or breast feeding.
- •Occupation or life situation that may be put at risk by participation in the study
- •History of shift work or rotating shifts in the month prior
- •Involvement as a driver in a motor vehicle accident during the past 2 years where the cause of the accident was attributed to driver sleepiness
- •Inability to sleep supine
研究者
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The study aims to confirm the effectiveness and safety of BF2.649 by comparing it with a placebo (a pharmacologically inactive product) for the treatment of excessive daytime sleepiness associated with Obstructive Sleep Apnoea treated by nCPAP.Patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS)MedDRA version: 14.1Level: LLTClassification code 10015595Term: Excessive daytime sleepinessSystem Organ Class: 100000004852EUCTR2009-017248-14-BGBIOPROJET280