A Phase 3 interventional study of Scopolamine Nasal Gel and Placebo in Motion Sickness, sponsored by Repurposed Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by Repurposed Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
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
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's enrollment of 300 is above the median of 64 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →Repurposed Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Having any of the following medical conditions within the last two years or if any of the following medical conditions were experienced more than two years ago and are deemed clinically significant by the PI or qualified designee:
DPI-386 Nasal Gel + placebo patch
Drug: Scopolamine Nasal Gel · Other: Placebo
placebo nasal gel + placebo patch
Other: Placebo
placebo nasal gel + TDS patch
Drug: Scopolamine Nasal Gel · Other: Placebo
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.
Also known as: Scopolamine Patch
placebo nasal gel + placebo patch
Also known as: Placebo Patch and Placebo Nasal Gel
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment during an 8 hour voyage
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment with Rescue medication during an 8 hour voyage on Treatment Day 1.
Time frame: During three consecutive days
Plan to share: No — In publication and CSR.
No publications or documents are linked to this record.
Ran from Apr 2019 to primary completion in May 2019, 0 months.
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Scopolamine
Repurposed Therapeutics, Inc.