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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: March 9, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Altitude Sickness
Drug: Ibuprofen
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Acute Mountain Sickness [ Time Frame: 2 days ]
    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 [ Time Frame: 2 days ]
    Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms


Enrollment: 89
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ibuprofen
600mg ibu TID
Drug: Ibuprofen
3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
Other Name: motrin
Placebo Comparator: placebo
visually identical
Drug: Placebo
identical number of visually identical tasteless pills as ibuprofen arm

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171794

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of California, San Diego
Investigators
Principal Investigator: Grant S Lipman Stanford University
  More Information

Responsible Party: Grant S Lipman, PI, Stanford University
ClinicalTrials.gov Identifier: NCT01171794     History of Changes
Other Study ID Numbers: SU-12012009-4443
Study First Received: July 27, 2010
Results First Received: October 8, 2014
Last Updated: March 9, 2017

Additional relevant MeSH terms:
Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Anti-Inflammatory Agents
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2017