Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-12

Study Completion Date

2017-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Mountain Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized double blind controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

visually identical pills

Study Groups

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Ibuprofen

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

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

non-steroidal anti-inflammatory drug

acetazolamide

acetazolamide, 125mg, two times a day, through to ascent to high altitude

Group Type ACTIVE_COMPARATOR

Acetazolamide

Intervention Type DRUG

a diuretic

Interventions

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Ibuprofen

non-steroidal anti-inflammatory drug

Intervention Type DRUG

Acetazolamide

a diuretic

Intervention Type DRUG

Other Intervention Names

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Motrin diamox

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes