Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310642
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2024-01-08
Brief Title:
Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness
Sponsor:
CHRISTUS Health
Organization:
CHRISTUS Health
Study Overview
Official Title:
A Prospective Single-Blinded Randomized Field-Based Trial to Evaluate the Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAMS
Brief Summary:
A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS andor 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None