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

NCT ID: NCT01171794

Last Updated: 2018-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Altitude Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ibuprofen

600mg ibu TID

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)

placebo

visually identical

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

identical number of visually identical tasteless pills as ibuprofen arm

Interventions

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Ibuprofen

3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)

Intervention Type DRUG

Placebo

identical number of visually identical tasteless pills as ibuprofen arm

Intervention Type DRUG

Other Intervention Names

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motrin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Grant S Lipman

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Grant S Lipman

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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Lipman GS, Kanaan NC, Holck PS, Constance BB, Gertsch JH; PAINS Group. Ibuprofen prevents altitude illness: a randomized controlled trial for prevention of altitude illness with nonsteroidal anti-inflammatories. Ann Emerg Med. 2012 Jun;59(6):484-90. doi: 10.1016/j.annemergmed.2012.01.019. Epub 2012 Mar 21.

Reference Type RESULT
PMID: 22440488 (View on PubMed)

Other Identifiers

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SU-12012009-4443

Identifier Type: -

Identifier Source: org_study_id