NCT01606527

NSAID RCT for Prevention of Altitude Sickness

Prospective, Double-blind, Randomized, Placebo-controlled Trial of Ibuprofen Versus Placebo for Prevention of Neurologic Forms of Altitude Sickness

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Naval Health Research Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Spectrum of Altitude-associated Neurologic Forms of Altitude

Interventions

Type	Name	Description
DRUG	Ibuprofen 600mg orally three times daily	Ibuprofen is taken 600mg orally three times daily

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-05-25
• Last updated: 2012-05-25

Locations

1 site across 1 country: United States