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

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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