Phase 3 N=89 Randomized Triple-blind Prevention

Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)

Altitude Sickness

Bottom Line

View on ClinicalTrials.gov: NCT01171794 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Acute Mountain Sickness — 19; 26 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ibuprofen (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Acute Mountain Sickness	19; 26	—
PRIMARY Acute Mountain Sickness Severity	3.2; 4.4	—

Summary

This is a research study on Altitude Illness. From the information collected and studied in this project we hope to learn more about Altitude Illness, including factors that may affect and prevent the development and progression of this condition. We hope to learn if the commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude illness. Possible participants in this study are healthy adults who indicated they would like to participate, learn about altitude illness, and desire to hike Barcroft Peak. Stanford University researchers hope to enroll about 100 participants.

Eligibility Criteria

Inclusion Criteria

Healthy Male or female volunteer
Age 18-65
Sea-level dwelling
Non pregnant
Have not been to high altitude in the past week
Can arrange for their own transportation to WMRS by friday evening the weekend of their study enrollment and are available the duration of the weekend of their study enrollment

Exclusion Criteria

Age 65
Live at altitude > Sea Level +/- 1000'
Pregnant
Taking NSAIDs, Acetazolamide, or Corticosteroids
Allergic to NSAIDs or Aspirin, or have had adverse reaction to them in the past
Traveled or planning to travel to high altitude in the week prior to their enrollment.
Medical history of Brain Tumor, increased intercranial pressure, pseudotumor cerebri, ventricular shunts, loss of an eye, Asthma, HACE or HAPE.
Cannot arrange for their own transportation to WMRS or are unavailable for the duration of the weekend of their study enrollment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01171794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.