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Antiemetic
Prochlorperazine for Altitude Sickness
Phase 2
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Individuals <18 years old or >75 years old
Individuals requiring supplemental baseline oxygen or with chronic disorders known to be significantly impacted by hypoxia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the primary outcome will be assessed during the discreet roughly 36 hour trial period. llqs will be administered the evening of and morning after arrival to peak altitude, or at any point of self reported altitude illness.
Awards & highlights
Summary
This trial is testing a drug called prochlorperazine to see if it can prevent acute mountain sickness. Participants will either take the drug or a fake pill (placebo) and go on a hike
Who is the study for?
This trial is for people who are healthy but at risk of acute mountain sickness. Participants will hike to and sleep at a high altitude. There's no detailed inclusion or exclusion criteria provided, so it's assumed that anyone meeting the general description can participate.
What is being tested?
The study tests Prochlorperazine Maleate, a drug used for nausea and headache, against a placebo to see if it prevents acute mountain sickness during a hike up Mount Blue Sky.
What are the potential side effects?
Prochlorperazine may cause drowsiness, dizziness, blurred vision, dry mouth, constipation or problems with urination. More serious effects could include movement disorders or severe allergic reactions.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am between 18 and 75 years old.
Select...
I need extra oxygen daily or have a condition worsened by low oxygen levels.
Select...
I am not taking dofetilide, potassium supplements, or Yohimbe.
Select...
I am unable to make my own medical decisions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the primary outcome will be assessed during the discreet roughly 36 hour trial period. llqs will be administered the evening of and morning after arrival to peak altitude, or at any point of self reported altitude illness.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the primary outcome will be assessed during the discreet roughly 36 hour trial period. llqs will be administered the evening of and morning after arrival to peak altitude, or at any point of self reported altitude illness.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Mountain Sickness
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Prochlorperazine MaleateExperimental Treatment1 Intervention
This arm will be the interventional/experimental arm receiving prochlorperazine maleate, further described in experimental arm section.
Group II: PlaceboPlacebo Group1 Intervention
The placebo arm individuals will receive a non-identical placebo.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,546 Total Patients Enrolled
8 Trials studying Altitude Sickness
461 Patients Enrolled for Altitude Sickness
Elan Small, MDStudy DirectorUniversity of Colorado, Denver
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