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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02244437 |
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Date of registration:
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14/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ibuprofen vs Acetaminophen for AMS Prevention
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Scientific title:
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Ibuprofen vs Acetaminophen in the Prevention of Acute Mountain Sickness: A Double Blind, Randomized Controlled Trial |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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288 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02244437 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Nepal
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Contacts
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Name:
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Nicholas C Kanaan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Surgery, Division of Emergency Medicine, University of Utah, Salt Lake City, UT, USA |
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Name:
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Matiram Pun, MBBS/MSc/MA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mountain Medicine Society of Nepal (MMSN) and Department of Clinical Physiology, Maharajgunj Medical Campus, Institute of Medicine (IOM), Kathmandu, Nepal |
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Name:
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Buddha Basnyat, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mountain Medicine Society of Nepal (MMSN), Nepal International Clinic (NIC) and Oxford University Clinical Research Unit (OUCRU), Kathmandu, Nepal |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy subjects between the ages of 18 and 65, male or female, non-Nepali, without
AMS or any concurrent illness, and not already taking NSAIDs and acetazolamide or any
other drug for the prevention of altitude illness. Subjects will be enrolled by study
administrators en route directly to Everest Base Camp or Kala Patthar between the
villages of Pheriche/Dingboche and Lobuche.
Exclusion Criteria:
- Individuals not meeting inclusion criteria, including mild AMS (more than one mild
symptom on the Lake Louise Questionnaire) or significantly depressed oxygen
saturation (<75%); females known to be pregnant, cannot exclude the possibility of
being pregnant, or have missed menses by over 7 days; individuals who have spent 24
hours at an altitude of 4500 meters/14,000 feet within the last 9 days; anyone known
to have taken any of the following in the last 2 days: acetazolamide (Diamox®),
steroids (dexamethasone, prednisone), theophylline, or diuretics (Lasix®);
individuals who have a known intracranial space occupying lesion or a history of
elevated intracranial pressure, (i.e. tumors, hydrocephalus, etc).
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Mountain Sickness, Blood Oxygen Saturation, Headache
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Intervention(s)
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Drug: Ibuprofen
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Drug: Acetaminophen
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Primary Outcome(s)
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Diagnosis of Acute Mountain Sickness (AMS)
[Time Frame: Upon reaching 5000m altitude (Lobuche) of Nepal Himalaya. Average stay of the trekkers at this altitude is expected about a day or more. The assessment of the participants will be done next day (after spending overnight) upon their arrival.]
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Secondary Outcome(s)
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Blood Oxygen Saturation (SPO2)
[Time Frame: Upon reaching 5000m altitude (Lobuche) of Nepal Himalaya. Average stay of the trekkers at this altitude is expected about a day or more. The assessment of the participants will be done next day (after spending overnight) upon their arrival.]
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Heart Rate (HR)
[Time Frame: Upon reaching 5000m altitude (Lobuche) of Nepal Himalaya. Average stay of the trekkers at this altitude is expected about a day or more. The assessment of the participants will be done next day (after spending overnight) upon their arrival.]
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High Altitude Headache (HAH)
[Time Frame: Upon reaching 5000m altitude (Lobuche) of Nepal Himalaya. Average stay of the trekkers at this altitude is expected about a day or more. The assessment of the participants will be done next day (after spending overnight) upon their arrival.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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