Motion Sickness Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion
This is a Phase 3, two-arm, randomized, double-blind, placebo-controlled, single dose efficacy and safety study evaluating the use of a nasal gel to prevent nausea and vomiting associated with motion
Eligible participants will be randomized 1:1 to DPI-386 Nasal Gel or matching placebo nasal gel and assigned a time and date for travel on an ocean vessel. Participants will be asked to self-administer the study medication while the ship is in harbor. The Modified Performance Self-Assessment Questionnaire (mPSAQ) will be completed by each participant prior to the administration of nasal gel, approximately every 30 minutes of travel, and at the end of travel. The participants will complete the Nausea Assessment Scale (NAS) every 30 minutes afer dosing, and at the end of travel. The participants will also be asked to complete a Sopite Assessment Questionnaire (SAQ) and a Patient Global Assessment of Severity (PGI-S) at 4 hours to describe their travel experience. All questionnaires will be submitted for analysis. An exit interview will also be conducted. The treatment phase will last approximately 4-5 hours ;
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