Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness
NCT ID: NCT06310642
Last Updated: 2024-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2021-05-20
2023-03-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness
NCT06450899
Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years
NCT03561675
Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness
NCT01522326
Sickness Evaluation at Altitude With Acetazolamide at Relative Doses
NCT03828474
Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects
NCT03988530
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prochlorperazine 10 mg
Subjects received 10 mg Prochlorperazine one time.
Immediate descent from altitude.
Immediate descent from altitude for severe symptoms or anyone who wished to discontinue their participation in the study.
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.
Prochlorperazine 10 mg
Subjects in the Prochlorperazine arm were administered 10mg PO Prochlorperazine immediately prior to ascent
Placebo
Subjects received Placebo one time.
Immediate descent from altitude.
Immediate descent from altitude for severe symptoms or anyone who wished to discontinue their participation in the study.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immediate descent from altitude.
Immediate descent from altitude for severe symptoms or anyone who wished to discontinue their participation in the study.
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.
Prochlorperazine 10 mg
Subjects in the Prochlorperazine arm were administered 10mg PO Prochlorperazine immediately prior to ascent
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CHRISTUS Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peter Richman, MD
Professor and Research Director, Department of Emergency Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Richman, MD
Role: PRINCIPAL_INVESTIGATOR
CHRISTUS Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency
Corpus Christi, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Smedley T, Grocott MP. Acute high-altitude illness: a clinically orientated review. Br J Pain. 2013 May;7(2):85-94. doi: 10.1177/2049463713489539.
Klocke DL, Decker WW, Stepanek J. Altitude-related illnesses. Mayo Clin Proc. 1998 Oct;73(10):988-92; quiz 992-3. doi: 10.4065/73.10.988.
Irons HR, Salas RN, Bhai SF, Gregorie WD, Harris NS. Prospective Double-Blinded Randomized Field-Based Clinical Trial of Metoclopramide and Ibuprofen for the Treatment of High Altitude Headache and Acute Mountain Sickness. Wilderness Environ Med. 2020 Mar;31(1):38-43. doi: 10.1016/j.wem.2019.11.005. Epub 2020 Feb 11.
Luks AM, Auerbach PS, Freer L, Grissom CK, Keyes LE, McIntosh SE, Rodway GW, Schoene RB, Zafren K, Hackett PH. Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Acute Altitude Illness: 2019 Update. Wilderness Environ Med. 2019 Dec;30(4S):S3-S18. doi: 10.1016/j.wem.2019.04.006. Epub 2019 Jun 24.
Netzer N, Strohl K, Faulhaber M, Gatterer H, Burtscher M. Hypoxia-related altitude illnesses. J Travel Med. 2013 Jul-Aug;20(4):247-55. doi: 10.1111/jtm.12017. Epub 2013 Mar 11.
Lu H, Wang R, Xiong J, Xie H, Kayser B, Jia ZP. In search for better pharmacological prophylaxis for acute mountain sickness: looking in other directions. Acta Physiol (Oxf). 2015 May;214(1):51-62. doi: 10.1111/apha.12490. Epub 2015 Mar 28.
Kanaan NC, Peterson AL, Pun M, Holck PS, Starling J, Basyal B, Freeman TF, Gehner JR, Keyes L, Levin DR, O'Leary CJ, Stuart KE, Thapa GB, Tiwari A, Velgersdyk JL, Zafren K, Basnyat B. Prophylactic Acetaminophen or Ibuprofen Results in Equivalent Acute Mountain Sickness Incidence at High Altitude: A Prospective Randomized Trial. Wilderness Environ Med. 2017 Jun;28(2):72-78. doi: 10.1016/j.wem.2016.12.011. Epub 2017 May 4.
Olson LG, Hensley MJ, Saunders NA. The effects of combined morphine and prochlorperazine on ventilatory control in humans. Am Rev Respir Dis. 1986 Apr;133(4):558-61. doi: 10.1164/arrd.1986.133.4.558.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-217
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.