NSAID RCT for Prevention of Altitude Sickness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Naval Health Research Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Jeffrey Gertsch MD, Naval Health Research Center
ClinicalTrials.gov Identifier:
NCT01606527
First received: April 13, 2012
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

The proposed study is a prospective, randomized, double-blind, placebo-controlled clinical trial evaluating ibuprofen and placebo for the prevention of neurological forms of altitude illness [including high altitude headache (HAH), acute mountain sickness (AMS), high altitude cerebral edema (HACE), and an emerging concept of High Altitude Anxiety]. The study will take place in the spring and summer of 2012 at the Marine Corps Mountain Warfare Training Center in the Eastern Sierras near Bridgeport, California. US Marines from near sea level will participate in battalion-level training exercises at between 8,500-11,500 Feet, where some altitude illness is expected. Concurrent measures used to determine objective markers of altitude illness, such that validated clinical scales, rapid cognitive screening tests, will inform us of symptoms of altitude illness.


Condition Intervention Phase
Spectrum of Altitude-associated Neurologic Forms of Altitude
Drug: Ibuprofen 600mg orally three times daily
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Prospective, Double-blind, Randomized, Placebo-controlled Trial of Ibuprofen Versus Placebo for Prevention of Neurologic Forms of Altitude Sickness

Resource links provided by NLM:


Further study details as provided by Naval Health Research Center:

Primary Outcome Measures:
  • Change in the incidence of AMS as measured on the Lake Louise AMS Questionnaire across the study. [ Time Frame: Twice daily ] [ Designated as safety issue: Yes ]
    The measure is assessed twice daily for four days


Secondary Outcome Measures:
  • 1. Change in High Altitude Headache measured by the Visual Analog Scale (VAS) across the study. [ Time Frame: Twice daily ] [ Designated as safety issue: Yes ]
    The measure is assessed twice daily for four days

  • 2. Change in cognitive performance as measured by King-Devick across the study. [ Time Frame: Twice daily ] [ Designated as safety issue: Yes ]
    The measure is assessed twice daily for four days

  • 3. Change in the presence of anxiety and somatic symptoms using the BSI-12 screening tool across the study [ Time Frame: Twice daily ] [ Designated as safety issue: Yes ]
    The measure is assessed twice daily for four days

  • 4. Change in the oxygen concentration using Pulse Oximetry across the study. [ Time Frame: Twice daily ] [ Designated as safety issue: Yes ]
    The measure is assessed twice daily for four days

  • 5. Change in hydration status as measured by urine specific gravity across the study. [ Time Frame: Twice daily ] [ Designated as safety issue: No ]
    The measure is assessed twice daily for four days

  • 6. Change in HAH incidence and severity as measured on the Lake Louise AMS Questionnaire across the study. [ Time Frame: Twice daily ] [ Designated as safety issue: Yes ]
    The measure is assessed daily for four days

  • 7. Change in cognitive performance as measured by the Quickstick across the study [ Time Frame: Twice daily ] [ Designated as safety issue: Yes ]
    The measure is assessed twice daily for four days

  • 8. Change in the presence of anxiety and somatic symptoms using the GAD-2 screening tool across the study [ Time Frame: Twice daily ] [ Designated as safety issue: Yes ]
    The measure is assesed twice daily for four days

  • 9. Incidence of severe AMS as measured by a score of 6 or greater on the Lake Louise AMS Questionnaire. [ Time Frame: Twice Daily ] [ Designated as safety issue: Yes ]
    The measure is assessed twice daily for four days


Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen
Ibuprofen 600mg taken three times daily for four days.
Drug: Ibuprofen 600mg orally three times daily
Ibuprofen is taken 600mg orally three times daily
Other Name: Motrin
Placebo Comparator: placebo
Avicel placebo capsules three times daily for four days
Drug: Ibuprofen 600mg orally three times daily
Ibuprofen is taken 600mg orally three times daily
Other Name: Motrin

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

Active duty military

Current in their medical screening

EXCLUSION CRITERIA:

Upper respiratory tract infection or influenza

Have had a reaction to Ibuprofen, aspirin or other Non-Steroidal Anti-inflammatory Drugs (NSAIDs).

Stayed the night at an altitude of greater than 6,700 feet within the last 7 days

Headache at baseline

Have altitude sickness or more than one mild symptom of any severity on the Lake Louise Questionnaire including headache, poor appetite, nausea, vomiting, fatigue, weakness, dizziness, and/or poor sleep (insomnia)

Low blood oxygen or low oxygen saturation (<90%)

Pregnant or cannot exclude the possibility of being pregnant, or have missed menses by over 7 days.

Have taken any of the following in 48 hours preceding enrollment: acetazolamide/Diamox, steroids (dexamethasone/Decadron, prednisone), theophylline, or diuretics such as Lasix

Have taken any of the following within 12 hours preceding enrollment: Ibuprofen/Motrin, Naprosyn/Naproxen/Aleve, aspirin, or Acetaminophen/Tylenol.

Have taken any other medication that may be known to have potential for drug-drug interactions with ibuprofen, including (but not limited to): ACE-inhibitor antihypertiensives, thiazide diuretics, furosemide, lithium, methotrexate, and H-2 Agonists.

Have any medical conditions which may make participation hazardous (*by self-report which can be clarified before enrollment with the study physicians as necessary), including:

  • Heart disease - Congestive heart failure, heart attack in the last month or severe coronary artery disease, or significant heart valve problems or other congenital problems.
  • Lung disease - Restrictive lung disease, chronic obstructive pulmonary disease (COPD), severe obstructive sleep apnea, or pulmonary hypertension of any cause.
  • Neurological disorders - Hydrocephalus, history of brain tumor, history of severe brain trauma or coma, pseudotumor cerebri, or severe uncontrolled headaches/migraine disorder (as diagnosed by a doctor).
  • Gastrointestinal - Known stomach ulcer or history of gastrointestinal bleeding.
  • Blood disorders - Anemia, leukemia, or other coagulopathies of any kind.
  • Kidney disease - Kidney failure or other known kidney disease.

General - The Principal Investigator and co-investigator reserve the right to exclude a potential participant with conditions that in their judgment are not listed above, but which would reasonably represent concern for the participant's health and welfare, including (but not limited to) conditions that may directly antagonize mechanisms of acclimatization to altitude, organ failure, metastatic/malignant neoplasm, space-occupying brain lesions or diagnoses typically known to raise intracranial pressure, and disorders that are likely to antagonize adequate respiration, blood oxygenation, and/or circulation.

  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: NCT01606527

Contacts
Contact: Jeffrey H Gertsch, MD 619-543-6891 jgertsch@ucsd.edu

Locations
United States, California
Marine Mountain Warfare Training Center Not yet recruiting
Bridgeport, California, United States
Contact: Darren Thomas, MD       darren.thomas@usmc.mil   
Sub-Investigator: Darren Thomas, MD         
Sponsors and Collaborators
Naval Health Research Center
University of California, San Diego
Investigators
Principal Investigator: Jeffrey H Gertsch, MD Naval Health Research Center - San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey Gertsch MD, Senior Scientist, Warfighter Performance Laboratory, Naval Health Research Center
ClinicalTrials.gov Identifier: NCT01606527     History of Changes
Other Study ID Numbers: NHRC.2012.0013
Study First Received: April 13, 2012
Last Updated: May 23, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Naval Health Research Center:
Spectrum of Altitude-associated acute mountain sickness
hypoxia
high altitude headache
high altitude cerebral edemat is.....

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

ClinicalTrials.gov processed this record on August 21, 2014