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Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness

NCT06310642 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-05-28

No results posted yet for this study

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.

Conditions

  • AMS
  • Acute Mountain Sickness

Interventions

OTHER

Immediate descent from altitude.

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

DRUG

Diphenhydramine

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

DRUG

Prochlorperazine 10 mg

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

Sponsors & Collaborators

  • CHRISTUS Health

    lead OTHER

Principal Investigators

  • Peter Richman, MD · CHRISTUS Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2023-03-13
Completion
2023-03-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06310642 on ClinicalTrials.gov