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

NCT01171794 | Completed Phase 3 Results DMC

• 1 other identifier: SU-12012009-4443
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Altitude Sickness

Outcome Measures

Primary Outcomes (2)

• 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

  2 days

• Acute Mountain Sickness Severity

  Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms

  2 days

Study Arms (2)

ibuprofen

ACTIVE COMPARATOR

600mg ibu TID

Drug: Ibuprofen

placebo

PLACEBO COMPARATOR

visually identical

Drug: Placebo

Interventions

Ibuprofen DRUG

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

Also known as: motrin

ibuprofen

Placebo DRUG

identical number of visually identical tasteless pills as ibuprofen arm

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• University of California, San Diego: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 22440488 RESULT

MeSH Terms

Conditions

Altitude Sickness

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Grant S Lipman ( PI)
• Organization: Stanford University School of Medicine

lipmangrant@gmail.com

4152909286

Study Officials

• Grant S Lipman

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 13, 2018
• Results First Posted: April 20, 2017

Record last verified: 2018-11

Locations

US (1)