Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450899
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-05-28
Brief Title:
Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a trial looking at a drug to help prevent acute mountain sickness The drug is prochlorperazine a drug commonly used to treat nausea vomiting and headache Participants will either take the drug or a placebo and hike to and sleep at the summit of Mount Blue Sky located at 4348 meters 14265 feet
Detailed Description:
This study will be a double-blind randomized controlled trial to investigate the utility of prochlorperazine maleate versus placebo for the chemoprophylaxis of acute mountain sickness on rapid ascent to 4348 meters specifically the summit of Mount Blue Sky in the Mount Blue Sky Wilderness Participants will be evaluated for AMS utilizing the 2018 LLQ both the evening of and morning after ascent The primary outcome will be the presence of AMS defined by a 2018 LLQ score equal to or greater than 3 including the presence of a headache at any measured point during the study Individuals will convene the morning of the study in Golden Colorado where they will receive breakfast and either placebo or prochlorperazine They will then be driven to Summit Lake where they will break for lunch and receive the second dose of placebo or prochlorperazine They will then hike to the Mount Blue Sky summit where they will receive their third and final dose of either placebo or intervention spend the night in the structures at the summit and be assessed for AMS via LLQ In the morning they will be assessed for AMS again receive breakfast and then be driven back to the original meeting point They will be monitored by Emergency Physicians at all points during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None