NSAID RCT for Prevention of Altitude Sickness

Phase 2

• Conditions: Spectrum of Altitude-associated Neurologic Forms of Altitude
• Interventions: Drug: Ibuprofen 600mg orally three times daily

• Registration Number: NCT01606527
• Lead Sponsor: Naval Health Research Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-13
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-23
• Last Update Submitted: 2012-05-23
• Study First Posted: 2012-05-25
• Last Update Posted: 2012-05-25
• Study Start: 2012-07
• Primary Completion: 2012-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen 600mg orally three times daily	Ibuprofen 600mg taken three times daily for four days.
placebo	Ibuprofen 600mg orally three times daily	Avicel placebo capsules three times daily for four days

Primary Outcome Measures

Name	Time	Method
Change in the incidence of AMS as measured on the Lake Louise AMS Questionnaire across the study.	Twice daily	The measure is assessed twice daily for four days

Secondary Outcome Measures

Name	Time	Method
1. Change in High Altitude Headache measured by the Visual Analog Scale (VAS) across the study.	Twice daily	The measure is assessed twice daily for four days
2. Change in cognitive performance as measured by King-Devick across the study.	Twice daily	The measure is assessed twice daily for four days
3. Change in the presence of anxiety and somatic symptoms using the BSI-12 screening tool across the study	Twice daily	The measure is assessed twice daily for four days
4. Change in the oxygen concentration using Pulse Oximetry across the study.	Twice daily	The measure is assessed twice daily for four days
5. Change in hydration status as measured by urine specific gravity across the study.	Twice daily	The measure is assessed twice daily for four days
6. Change in HAH incidence and severity as measured on the Lake Louise AMS Questionnaire across the study.	Twice daily	The measure is assessed daily for four days
7. Change in cognitive performance as measured by the Quickstick across the study	Twice daily	The measure is assessed twice daily for four days
8. Change in the presence of anxiety and somatic symptoms using the GAD-2 screening tool across the study	Twice daily	The measure is assesed twice daily for four days
9. Incidence of severe AMS as measured by a score of 6 or greater on the Lake Louise AMS Questionnaire.	Twice Daily	The measure is assessed twice daily for four days

Trial Locations

Locations (1)

Marine Mountain Warfare Training Center; 🇺🇸 Bridgeport, California, United States