The Prevention and Treatment of Nausea Associated With Motion Sickness
Status:
Completed
Trial end date:
2019-06-19
Target enrollment:
Participant gender:
Summary
This single-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled
study to identify the safety and efficacy of a repeated-dose regimen 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 an ocean going vessel to obtain data in a
real world environment. The study will have three arms: DPI-386 nasal gel, placebo nasal gel,
and TDS patch (1.5 mg/72 hours), the current standard of care for the treatment of motion
sickness. The study will include 100 subjects per arm, for a total of 300 subjects (n=300).
Multiple voyages with the same vessel will be used until the required enrollment is
completed. A double dummy design will be used to mask the treatment assignment. All subjects
will receive both a patch and nasal gel randomized to one of the following three arms:
DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, and placebo nasal gel +
TDS patch.