Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT01171794
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2010-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This study was designed to bring together elements of prior studies and go one step further for definitive data on several points. The trial will employ two pharmaceutical intervention arms, which will compare placebo (the standard of care - information on prevention of altitude sickness) with the widely used NSAID ibuprofen. We will also determine Optic Nerve Sheath Diameter (ONSD) measurements via ultrasound in both the control and interventional arms. We will accomplish these objectives with a prospective, double blinded view of a large population of hikers who are ascending at their own rate in a true hiking environment: The White Mountain Research Station Owen Valley Lab (OVL) and Bancroft Station (BAR).
Primary hypothesis: Ibuprofen 600 mg TID will be superior to placebo in decreasing both the incidence and severity of AMS in high altitude travel.
Primary hypothesis: Ibuprofen 600 mg TID will be superior to placebo in decreasing both the incidence and severity of AMS in high altitude travel.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: