The Prevention and Treatment of Nausea Associated With Motion Sickness
Condition: Motion Sickness
MeSH terms: Motion Sickness
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The investigational product will be administered using a delivery device comprised of: (a) a
      vial prefilled with DPI-386 Nasal Gel or placebo nasal gel, and (b) a nasal gel pump attached
      to the vial during the manufacturing process. Each 0.12 gram of the gel contains 0.2 mg of
      scopolamine HBr as the active ingredient along with the excipients sodium citrate, citric
      acid, sodium metabisulfite, glycerin, benzalkonium chloride, polyvinyl alcohol and purified
      water. The DPI 386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.12 g dose,
      with each dose therefore described as "0.2 mg / 0.12 g". The placebo nasal gel product is the
      same but does not contain scopolamine HBr. Each vial of DPI 386 Nasal Gel or placebo nasal
      gel is a multi-dose product, sufficient for three days of dosing (two doses per day). Each
      pumping action is designed to deliver a single 0.12 g dose. Each vial/delivery device must be
      primed by the subject prior to first dose delivery for that vial. Each time a new bottle is
      used, it needs to be initially primed with 5 actuations. The 6th actuation is the first dose
      and subsequent actuations are doses 2-6 of that bottle. No re-priming is needed at all.
      Subjects will be trained in priming by research staff, and all priming will be performed
      under supervision by the research staff. All subjects will self-administer the nasal gel
      twice daily over the three day treatment period, with no more than two doses every 24 hours,
      unless a third dose is deemed necessary by the PI or qualified designee, and the two daily
      doses separated by a minimum of six hours ± 15 minutes
    

Intervention name(s): Scopolamine Nasal Gel; Placebo
Intervention type(s): Drug; Other
Intervention description(s): All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.; placebo nasal gel + placebo patch
Other intervention name(s): Scopolamine Patch; Placebo Patch and Placebo Nasal Gel
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment