Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

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Brief Title

Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Official Title

Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Brief Summary

      This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention
      of acute mountain sickness. These drugs have never been directly compared for efficacy. The
      study population is hikers who are ascending at their own rate under their own power in a
      true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and
      Bancroft Station (BAR), Bancroft Peak, White Mountain, California.
    

Detailed Description

      The specific aim of this study is to evaluate if acetazolamide will be similar to ibuprofen
      (i.e. Ibuprofen being non-inferior) in decreasing the incidence of Acute Mountain Sickness
      (AMS) in travelers to high altitude. It has been shown that ibuprofen taken 3 times a day 6
      hours prior to ascent is effective for the prevention of AMS, with a number needed to treat
      of 4, decreasing the odds of getting AMS by a third. The efficacy appears to be similar to
      acetazolamide, with a NNT of 3 -8, although these two medications have not been directly
      compared in prevention of AMS. Acetazolamide is diuretic that is the only FDA approved AMS
      prophylactic medication and the most commonly used drug for AMS prevention. Although
      acetazolamide has been given a 1A indication, it has been shown to limit exercise
      capabilities at high altitude, and rapid ascent has been shown to attenuate its protective
      effects. Ibuprofen has been given a IIB recommendation by the Wilderness Medical Society
      Practice Guidelines, in part because it has not directly compared to acetazolamide. It is
      unknown if a non-steroidal anti-inflammatory can provide protection from AMS equivalent to
      acetazolamide.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

incidence of acute mountain sickness

Secondary Outcome

 severity of acute mountain sickness

Condition

Acute Mountain Sickness

Intervention

Ibuprofen

Study Arms / Comparison Groups

 Ibuprofen
Description:  ibuprofen, 600mg, three times a day, through to ascent to high altitude

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

92

Start Date

August 12, 2017

Completion Date

October 1, 2017

Primary Completion Date

October 1, 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Age 18-65 healthy non-pregnant volunteer

          2. Sea-level dwelling (live at low elevation < 4000 ft)

          3. Arrange your own transportation to WMRS (Bishop) by Friday evening of study weekend

          4. Available for full study duration (Friday PM-Sunday AM)

        Exclusion Criteria:

          1. Age <18 or >65, Pregnant, Live at altitude >4000 ft

          2. Slept at altitude > 4000ft within 1 week of study

          3. Allergic to acetazolamide, sulfa drugs, or non-steroidal anti-inflammatories

          4. Taking NSAIDs, Acetazolamide, or Corticosteroids 1 week prior to study

          5. Medical History of Brain Tumor, increased brain pressure, pseudotumor cerebri, VP
             shunts, HACE, or HAPE.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03154645

Organization ID

40325


Responsible Party

Sponsor-Investigator

Study Sponsor

Grant S Lipman


Study Sponsor

, , 


Verification Date

November 2018