CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Diphenhydramine +2 moredrug
Likely dose
Prochlorperazine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06310642
NCT06310642Phase 4Completed

A Prospective Single-Blinded Randomized Field-Based Trial to Evaluate the Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness

CHRISTUS Health·interventional·Posted Mar 15, 2024·Updated May 28, 2024

In Brief

A Phase 4 clinical trial evaluating Immediate descent from altitude., Diphenhydramine, and 1 other intervention for AMS and Acute Mountain Sickness. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 15, 2024
Enrollment StartMay 20, 2021
Primary CompletionMar 13, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 2.3 years ago

Interventions

Immediate descent from altitude.other

Immediate descent from altitude for severe symptoms or anyone who wished to discontinue their participation in the study.

Diphenhydraminedrug

Diphenhydramine was available to counteract any potential extrapyramidal side effects of the study drug. The use of Diphenhydramine for this purpose is well established.

Prochlorperazine 10 mgdrug

Subjects in the Prochlorperazine arm were administered 10mg PO Prochlorperazine immediately prior to ascent