Brief Title
Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)
Official Title
Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Acute Mountain Sickness
Condition
Altitude Sickness
Intervention
Ibuprofen
Study Arms / Comparison Groups
ibuprofen
Description: 600mg ibu TID
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
89
Start Date
July 2010
Completion Date
August 2010
Primary Completion Date
August 2010
Eligibility Criteria
Inclusion Criteria: 1. Healthy Male or female volunteer 2. Age 18-65 3. Sea-level dwelling 4. Non pregnant 5. Have not been to high altitude in the past week 6. 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: 1. Age <18 or >65 2. Live at altitude > Sea Level +/- 1000' 3. Pregnant 4. Taking NSAIDs, Acetazolamide, or Corticosteroids 5. Allergic to NSAIDs or Aspirin, or have had adverse reaction to them in the past 6. Traveled or planning to travel to high altitude in the week prior to their enrollment. 7. Medical history of Brain Tumor, increased intercranial pressure, pseudotumor cerebri, ventricular shunts, loss of an eye, Asthma, HACE or HAPE. 8. Cannot arrange for their own transportation to WMRS or are unavailable for the duration of the weekend of their study enrollment
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Grant S Lipman, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01171794
Organization ID
SU-12012009-4443
Responsible Party
Principal Investigator
Study Sponsor
Stanford University
Collaborators
University of California, San Diego
Study Sponsor
Grant S Lipman, Principal Investigator, Stanford University
Verification Date
November 2018