A Phase 4 interventional study of Immediate descent from altitude. and Diphenhydramine in AMS and Acute Mountain Sickness, sponsored by CHRISTUS Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by CHRISTUS Health · Phase 4, Interventional, and Treatment
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.
This was a prospective, single-blinded, field-based interventional trial involving consenting, healthy subjects aged >17 years. The study was conducted on the big Island of Hawaii, at sea level and at the summit of Mauna Kea volcano. Following randomization, subjects received either placebo or 10mg prochlorperazine, then immediately drove for 2 hours from sea level to the volcano summit (4205m). Participants spent 240 min at the summit, and they recorded their symptoms. AMS was defined by the previously validated Lake Louise Acute Mountain Sickness Score (LLAMS). Categorical variables were analyzed by chi-square; continuous variables analyzed by t-tests.
189 studies on the registry are indexed under Altitude Sickness; 44 are open to participants now.
This study's enrollment of 30 is close to the median of 33 across 157 interventional studies indexed under Altitude Sickness.
Browse Altitude Sickness studies →CHRISTUS Health is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Inclusion Criteria - Healthy subjects aged >17 years
Exclusion criteria-subject meets any of the following:
Subjects received 10 mg Prochlorperazine one time.
Other: Immediate descent from altitude. · Drug: Diphenhydramine · Drug: Prochlorperazine 10 mg
Subjects received Placebo one time.
Other: Immediate descent from altitude. · Drug: Diphenhydramine
Immediate descent from altitude for severe symptoms or anyone who wished to discontinue their participation in the study.
Diphenhydramine was available to counteract any potential extrapyramidal side effects of the study drug. The use of Diphenhydramine for this purpose is well established.
Also known as: Benadryl
Subjects in the Prochlorperazine arm were administered 10mg PO Prochlorperazine immediately prior to ascent
Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups
The study drug was administered at sea level (time 0). Immediately thereafter, participants drove 120 minutes to the summit. They spent an additional 240 minutes at the summit. Symptoms were recorded 360 minutes after drug administration while still at the summit. The primary outcome was the difference in mean LLAMS scores between the prochlorperazine and placebo groups (t-tests). Previously validated Lake Louise Acute Mountain Sickness Score (LLAMS) were utilized. Categorical variables were analyzed by chi-square; continuous variables analyzed by t-tests.
Time frame: 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)
Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups
The study drug was administered at sea level (time 0). Immediately thereafter, participants drove 120 minutes to the summit. They spent an additional 240 minutes at the summit. Symptoms were recorded 360 minutes after drug administration while still at the summit. Acute mountain sickness defined as having a headache score of at least one point, and a total score of at least three points. The prochlorperazine and placebo groups were compared for incidence of acute mountain sickness (chi-square)
Time frame: 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)
Plan to share: No — No plan.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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