Acute Mountain Sickness Clinical Trial
Official title:
Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness
NCT number | NCT06450899 |
Other study ID # | 23-0958 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 2024 |
Est. completion date | July 2025 |
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 4,348 meters (14,265 feet).
Status | Recruiting |
Enrollment | 62 |
Est. completion date | July 2025 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Adults >18 years old. Exclusion Criteria: - Individuals <18 years old or >75 years old - Pregnant women - Individuals who reside at or have slept at elevations >1,800 meters in the last two weeks - Individuals having taken acetazolamide, steroids, ibuprofen, anti-emetics or additional analgesics within the last 24 hours prior to study initiation - Individuals requiring supplemental baseline oxygen or with chronic disorders known to be significantly impacted by hypoxia - Individuals with known allergies to prochlorperazine or phenothiazines - Individuals taking medications with significant medication interactions with prochlorperazine: Dofetilide, potassium acid phosphate, potassium chloride, potassium citrate, potassium phosphate, Yohimbe. - Individuals with a history of dementia - Individuals who lack decision making capacity |
Country | Name | City | State |
---|---|---|---|
United States | Mount Blue Sky | Evergreen | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute Mountain Sickness | The primary outcome will be the presence of AMS, defined by a 2018 Lake Louise Questionnaire (LLQ) score of equal to or greater than 3, including the presence of a headache at any measured point during the study. | 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. |
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