Study of the Safety and Efficacy of DPI-386 Nasal Gel on Ocean-Going Vessels
Status:
Unknown status
Trial end date:
2021-03-01
Target enrollment:
Participant gender:
Summary
This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled
study to identify the safety and efficacy of DPI 386 nasal gel (intranasal scopolamine gel)
for the prevention and treatment of nausea associated with motion sickness. The study will be
conducted aboard military ships undergoing military operations or aboard commercial boats
rented for the study to obtain data in a real world environment. The study will have three
arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.0 mg/72 hours; transdermal
scopolamine patch [TDS], the current standard of care for the treatment of motion sickness).
The study will include 120 subjects per arm, for a total of 360 subjects (n=360). A
double-dummy design will be used to mask the treatment assignment. All subjects will receive
both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo
patch, or TDS patch + placebo nasal gel.