CompletedPhase 4

Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness

United States30 participantsStarted 2021-05-20

Plain-language summary

A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria - Healthy subjects aged \>17 years Exclusion criteria-subject meets any of the following: * Known allergy or contraindication to the study drug. * Known or suspected pregnancy. * Use of another analgesic or antiemetic within 8 hours of enrollment. * History of chronic headaches. * Inability to provide informed consent. * Use of central nervous system depressants, including alcohol, opiates, and/or barbiturates, within 24 hours of the study start time. * History of severe depression. * History of dementia. * Prior ascent and stay at 2500m for duration over 6 weeks within 30 days prior.

What they're measuring

Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups

Timeframe: LLAMS Scores were recorded 360 minutes post study drug administration (which equals 120 minutes of driving time to the summit and an additional 240 minutes spent at the summit)

Trial details

NCT IDNCT06310642

SponsorCHRISTUS Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-13

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