Spectrum of Altitude-associated Neurologic Forms of AltitudePhase 2NCT01606527
NSAID RCT for Prevention of Altitude Sickness
A Phase 2 study testing Ibuprofen 600mg orally three times daily in people with Spectrum of Altitude-associated Neurologic Forms of Altitude, run by Naval Health Research Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spectrum of Altitude-associated Neurologic Forms of Altitude
- What is being tested?
- Ibuprofen 600mg orally three times daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active duty military
- Current in their medical screening
Who cannot join
- 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%)
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Marine Mountain Warfare Training Center
Bridgeport, California
Darren Thomas, MD, darren.thomas@usmc.mil
Darren Thomas, MD
About this study
Official title: Prospective, Double-blind, Randomized, Placebo-controlled Trial of Ibuprofen Versus Placebo for Prevention of Neurologic Forms of Altitude Sickness
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.
- Being tested
- Ibuprofen 600mg orally three times daily
- Keywords
- Spectrum of Altitude-associated acute mountain sickness, hypoxia, high altitude headache, high altitude cerebral edemat is.....
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 600mg orally three times dailyDrug
Also called Motrin
Ibuprofen is taken 600mg orally three times daily
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Ibuprofen 600mg taken three times daily for four days. Receives: Drug: Ibuprofen 600mg orally three times daily |
| placebo | Placebo comparator | Avicel placebo capsules three times daily for four days Receives: Drug: Ibuprofen 600mg orally three times daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the incidence of AMS as measured on the Lake Louise AMS Questionnaire across the study.
The measure is assessed twice daily for four days
Measured: Twice daily
Secondary outcomes (9)
1. Change in High Altitude Headache measured by the Visual Analog Scale (VAS) across the study.
The measure is assessed twice daily for four days
Measured: Twice daily
2. Change in cognitive performance as measured by King-Devick across the study.
The measure is assessed twice daily for four days
Measured: Twice daily
3. Change in the presence of anxiety and somatic symptoms using the BSI-12 screening tool across the study
The measure is assessed twice daily for four days
Measured: Twice daily
4. Change in the oxygen concentration using Pulse Oximetry across the study.
The measure is assessed twice daily for four days
Measured: Twice daily
5. Change in hydration status as measured by urine specific gravity across the study.
The measure is assessed twice daily for four days
Measured: Twice daily
6. Change in HAH incidence and severity as measured on the Lake Louise AMS Questionnaire across the study.
The measure is assessed daily for four days
Measured: Twice daily
7. Change in cognitive performance as measured by the Quickstick across the study
The measure is assessed twice daily for four days
Measured: Twice daily
8. Change in the presence of anxiety and somatic symptoms using the GAD-2 screening tool across the study
The measure is assesed twice daily for four days
Measured: Twice daily
9. Incidence of severe AMS as measured by a score of 6 or greater on the Lake Louise AMS Questionnaire.
The measure is assessed twice daily for four days
Measured: Twice Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spectrum of Altitude-associated Neurologic Forms of AltitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naval Health Research Center
- Sponsor type
- US federal agency
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Jeffrey Gertsch MD, Naval Health Research Center
- Investigators
- Jeffrey H Gertsch, MD, Principal investigator, Naval Health Research Center - San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606527
- Sponsor's protocol ID
- NHRC.2012.0013
- Status last verified
- May 2012
- First submitted
- 13 Apr 2012
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-blind, Randomized, Placebo-controlled Trial of Ibuprofen Versus Placebo for Prevention of Neurologic Forms of Altitude Sickness
- ClinicalTrials.gov ID
- NCT01606527
- Acronym / sponsor ID
- NHRC.2012.0013
- Keywords
- Spectrum of Altitude-associated acute mountain sickness, hypoxia, high altitude headache, high altitude cerebral edemat is.....
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Naval Health Research CenterUS federal agency
- Collaborators
- University of California, San Diego
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: Ibuprofen 600mg orally three times dailyIbuprofen 600mg taken three times daily for four days. |
| placebo | Placebo comparator | Drug: Ibuprofen 600mg orally three times dailyAvicel placebo capsules three times daily for four days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active duty military
- Current in their medical screening
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 600mg orally three times dailyAlso: MotrinIbuprofen is taken 600mg orally three times daily | Drug | Ibuprofen, placebo |
Primary outcome
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
9 secondary outcomes
1. Change in High Altitude Headache measured by the Visual Analog Scale (VAS) across the study.
Time frame: Twice daily
2. Change in cognitive performance as measured by King-Devick across the study.
Time frame: Twice daily
3. Change in the presence of anxiety and somatic symptoms using the BSI-12 screening tool across the study
Time frame: Twice daily
4. Change in the oxygen concentration using Pulse Oximetry across the study.
Time frame: Twice daily
5. Change in hydration status as measured by urine specific gravity across the study.
Time frame: Twice daily
6. Change in HAH incidence and severity as measured on the Lake Louise AMS Questionnaire across the study.
Time frame: Twice daily
7. Change in cognitive performance as measured by the Quickstick across the study
Time frame: Twice daily
8. Change in the presence of anxiety and somatic symptoms using the GAD-2 screening tool across the study
Time frame: Twice daily
9. Incidence of severe AMS as measured by a score of 6 or greater on the Lake Louise AMS Questionnaire.
Time frame: Twice Daily
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey H Gertsch, MD principal investigator
Naval Health Research Center - San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibuprofen 600mg orally three times daily in people with Spectrum of Altitude-associated Neurologic Forms of Altitude, run by Naval Health Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey H Gertsch, MD (619-543-6891, jgertsch@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the incidence of AMS as measured on the Lake Louise AMS Questionnaire across the study. (time frame: Twice daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2012.