NCT03988530

Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI-386 Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects With Open-Label Follow-Up

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Repurposed Therapeutics, Inc. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI 386 Nasal Gel for the Prevention and Treatment of Nausea Associated with Motion Sickness in Senior Subjects With Open-Label Follow-Up

Detailed description

This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study with open-label follow-up to identify the safety, efficacy and pharmacokinetics 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 have two arms: DPI-386 nasal gel and placebo nasal gel for Treatment Day 1. Treatment Day 1 will include 50 subjects per arm, for a total of 100 subjects (n=100). All 100 subjects from Treatment Day 1 will receive open-label DPI-386 Nasal Gel for Treatment Days 2-4 (50 of these were originally randomized to receive placebo prior to receipt of the investigational product.). Treatment Day 1 will be conducted aboard an ocean-going vessel to obtain data in an operationally relevant real world environment and within 30 days of Treatment Day 1, Treatment Days 2-4 will take place at the clinical site.

Conditions

• Motion Sickness

Interventions

Type	Name	Description
DRUG	Scopolamine	Subjects will self-administer DPI-386 Nasal Gel (0.2 mg / 0.12 g) or placebo nasal gel (0.12 g) on Treatment Day 1, and on Treatment Days 2 -4 all subjects will self administer DPI-386 Nasal Gel (0.2 mg / 0.12 g).
OTHER	Placebo Nasal Gel	Placebo Nasal Gel (0.12g) twice a day on Treatment Day 1.

Timeline

• Start date: 2019-06-07
• Primary completion: 2020-11-23
• Completion: 2020-11-23
• First posted: 2019-06-17
• Last updated: 2023-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study