Prospective, Double-blind, Randomized, Placebo-controlled Trial of Ibuprofen Versus Placebo for Prevention of Neurologic Forms of Altitude Sickness
试验速览
- 阶段
- 2 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in the incidence of AMS as measured on the Lake Louise AMS Questionnaire across the study.
研究概览
简要总结
The proposed study is a prospective, randomized, double-blind, placebo-controlled clinical trial evaluating ibuprofen and placebo for the prevention of neurological forms of altitude illness [including high altitude headache (HAH), acute mountain sickness (AMS), high altitude cerebral edema (HACE), and an emerging concept of High Altitude Anxiety]. The study will take place in the spring and summer of 2012 at the Marine Corps Mountain Warfare Training Center in the Eastern Sierras near Bridgeport, California. US Marines from near sea level will participate in battalion-level training exercises at between 8,500-11,500 Feet, where some altitude illness is expected. Concurrent measures used to determine objective markers of altitude illness, such that validated clinical scales, rapid cognitive screening tests, will inform us of symptoms of altitude illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ibuprofen
Ibuprofen 600mg taken three times daily for four days.
干预措施: Ibuprofen 600mg orally three times daily (Drug)
placebo
Avicel placebo capsules three times daily for four days
干预措施: Ibuprofen 600mg orally three times daily (Drug)
结局指标
主要结局
Change in the incidence of AMS as measured on the Lake Louise AMS Questionnaire across the study.
时间窗: Twice daily
The measure is assessed twice daily for four days
次要结局
- 1. Change in High Altitude Headache measured by the Visual Analog Scale (VAS) across the study.(Twice daily)
- 2. Change in cognitive performance as measured by King-Devick across the study.(Twice daily)
- 3. Change in the presence of anxiety and somatic symptoms using the BSI-12 screening tool across the study(Twice daily)
- 4. Change in the oxygen concentration using Pulse Oximetry across the study.(Twice daily)
- 5. Change in hydration status as measured by urine specific gravity across the study.(Twice daily)
- 6. Change in HAH incidence and severity as measured on the Lake Louise AMS Questionnaire across the study.(Twice daily)
- 7. Change in cognitive performance as measured by the Quickstick across the study(Twice daily)
- 8. Change in the presence of anxiety and somatic symptoms using the GAD-2 screening tool across the study(Twice daily)
- 9. Incidence of severe AMS as measured by a score of 6 or greater on the Lake Louise AMS Questionnaire.(Twice Daily)
研究者
Jeffrey Gertsch MD
Senior Scientist, Warfighter Performance Laboratory
Naval Health Research Center