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

Primary Purpose

Altitude Sickness

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Altitude Sickness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ibuprofen

placebo

Arm Description

600mg ibu TID

visually identical

Outcomes

Primary Outcome Measures

Acute Mountain Sickness
Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness
Acute Mountain Sickness Severity
Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms

Secondary Outcome Measures

Full Information

First Posted
July 27, 2010
Last Updated
November 21, 2018
Sponsor
Stanford University
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01171794
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Altitude Sickness

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ibuprofen
Arm Type
Active Comparator
Arm Description
600mg ibu TID
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
visually identical
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
motrin
Intervention Description
3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
identical number of visually identical tasteless pills as ibuprofen arm
Primary Outcome Measure Information:
Title
Acute Mountain Sickness
Description
Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness
Time Frame
2 days
Title
Acute Mountain Sickness Severity
Description
Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Male or female volunteer Age 18-65 Sea-level dwelling Non pregnant Have not been to high altitude in the past week 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: Age <18 or >65 Live at altitude > Sea Level +/- 1000' Pregnant Taking NSAIDs, Acetazolamide, or Corticosteroids Allergic to NSAIDs or Aspirin, or have had adverse reaction to them in the past Traveled or planning to travel to high altitude in the week prior to their enrollment. Medical history of Brain Tumor, increased intercranial pressure, pseudotumor cerebri, ventricular shunts, loss of an eye, Asthma, HACE or HAPE. Cannot arrange for their own transportation to WMRS or are unavailable for the duration of the weekend of their study enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant S Lipman
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22440488
Citation
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.
Results Reference
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Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)

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