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

This study has been completed.

Sponsor:

Collaborator:

University of California, San Diego

Information provided by (Responsible Party):

Grant S Lipman, Stanford University

ClinicalTrials.gov Identifier:

NCT01171794

First received: July 27, 2010

Last updated: June 5, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 27, 2010

Last Updated Date

June 5, 2012

Start Date ^ICMJE

July 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Acute Mountain Sickness via Lake Louis Score [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01171794 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Optic Never Sheath Diameter via Occular Ultrasound [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Altitude Sickness

Intervention ^ICMJE

Drug: Ibuprofen

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01171794

Other Study ID Numbers ^ICMJE

SU-12012009-4443

Has Data Monitoring Committee

Not Provided

Responsible Party

Grant S Lipman, Stanford University

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

University of California, San Diego

Investigators ^ICMJE

Principal Investigator:

Grant S Lipman

Stanford University

Information Provided By

Stanford University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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