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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
320
Current Motion Sickness treatment, 1 patch behind the ear.
IND, up to 6 administration of intranasal gel.
Placebo Patch, 1 patch behind the ear.
Placebo Gel,up to 6 administration of intranasal gel.
NAMRU Dayton
Dayton, Ohio, United States
RECRUITINGDetermine the efficacy of DPI-386 nasal gel compared to the TDS patch and placebo nasal gel in the prevention and treatment of nausea associated with motion sickness.
The efficacy endpoint will be determined by comparing the Motion Sickness Assessment Questionnaire (MSAQ)(scale 1-10) scores over the treatment period across all three treatment arms
Time frame: Through study completion, an average of 1 year
Determine the safety of DPI-386 Nasal Gel compared to the TDS patch and placebo nasal gel with an emphasis on cognitive effects.
the safety endpoint is the incidence of adverse events.
Time frame: Through study completion, an average of 1 year
Determine the efficacy of DPI-386 Nasal Gel compared to the TDS patch and the placebo nasal gel in severity of nausea.
Severity of nausea will measured by the Nausea Assessment (VAS)(scale 1-9) over the treatment period.
Time frame: Through study completion, an average of 1 year
Determine the safety of DPI-386 Nasal Gel as compared to the TDS patch and placebo nasal gel in terms of cognition.
Safety in terms of cognition will be measured by Computer task.
Time frame: Through study completion, an average of 1 year
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