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NSAID RCT for Prevention of Altitude Sickness

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ClinicalTrials.gov Identifier: NCT01606527
Recruitment Status : Unknown
Verified May 2012 by Jeffrey Gertsch MD, Naval Health Research Center.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2012
Last Update Posted : May 25, 2012
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Jeffrey Gertsch MD, Naval Health Research Center

Tracking Information
First Submitted Date  ICMJE April 13, 2012
First Posted Date  ICMJE May 25, 2012
Last Update Posted Date May 25, 2012
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
Change in the incidence of AMS as measured on the Lake Louise AMS Questionnaire across the study. [ Time Frame: Twice daily ]
The measure is assessed twice daily for four days
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
  • 1. Change in High Altitude Headache measured by the Visual Analog Scale (VAS) across the study. [ Time Frame: Twice daily ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    The measure is assessed twice daily for four days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NSAID RCT for Prevention of Altitude Sickness
Official Title  ICMJE Prospective, Double-blind, Randomized, Placebo-controlled Trial of Ibuprofen Versus Placebo for Prevention of Neurologic Forms of Altitude Sickness
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Spectrum of Altitude-associated Neurologic Forms of Altitude
Intervention  ICMJE Drug: Ibuprofen 600mg orally three times daily
Ibuprofen is taken 600mg orally three times daily
Other Name: Motrin
Study Arms  ICMJE
  • Experimental: Ibuprofen
    Ibuprofen 600mg taken three times daily for four days.
    Intervention: Drug: Ibuprofen 600mg orally three times daily
  • Placebo Comparator: placebo
    Avicel placebo capsules three times daily for four days
    Intervention: Drug: Ibuprofen 600mg orally three times daily
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2012)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2012
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01606527
Other Study ID Numbers  ICMJE NHRC.2012.0013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey Gertsch MD, Naval Health Research Center
Study Sponsor  ICMJE Naval Health Research Center
Collaborators  ICMJE University of California, San Diego
Investigators  ICMJE
Principal Investigator: Jeffrey H Gertsch, MD Naval Health Research Center - San Diego
PRS Account Naval Health Research Center
Verification Date May 2012

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