NCT04219982

DPI 386 Nasal Gel for the Prevention of Nausea Associated With Motion Sickness

A Randomized, Double-Blind Placebo-Controlled Phase 3 Study of the Safety, Pharmacokinetics, and Efficacy of DPI 386 Nasal Gel for the Prevention of Nausea Associated With Motion Sickness

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Repurposed Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

Determine the efficacy, in terms of time to nausea (inclination to vomit), of DPI-386 Nasal Gel as compared to the current standard of care (TDS) and placebo nasal gel. • Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel (0.2 mg twice a day for six consecutive days) as compared to the current standard of care (TDS). Determine the safety of a multi-dose schedule of DPI-386 Nasal Gel with an emphasis on cognitive adverse events as compared to the current standard of care (TDS) and placebo nasal gel. Determine how alertness is affected by administration of DPI-386 Nasal Gel, as compared to the current standard of care (TDS) and placebo nasal gel.

Detailed description

Each subject eligible for the study on Day 0 will be assigned a subject number (starting with 101 for male subjects and 201 for female subjects) in consecutive order which will randomize the subject to one of the three study arms: double-blind DPI-386 Nasal Gel; double-blind placebo nasal gel; or Transderm Scop® (TDS). The subject number will link the nasal gel (active or placebo) treatment arms (double-blind) to a multi digit random number (study drug kit number) different from the subject number. The nasal gel vials, contained in the study drug kit, will be labelled with the same study drug kit number. 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.

Conditions

• Motion Sickness

Interventions

Type	Name	Description
DRUG	DPI-386 Nasal Gel	Nasal gel
DRUG	DPI-386 Placebo Nasal Gel	DPI-386 Placebo Nasal Gel
DRUG	Transderm Scop®	Transderm Scop®

Timeline

• Start date: 2018-06-29
• Primary completion: 2019-01-28
• Completion: 2019-01-28
• First posted: 2020-01-07
• Last updated: 2020-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study