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The Prevention and Treatment of Nausea Associated With Motion Sickness

NCT03986905 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-12-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Scopolamine Nasal Gel

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.

OTHER

Placebo

placebo nasal gel + placebo patch

Sponsors & Collaborators

  • Repurposed Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Dave Helton · Repurposed Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-26
Primary Completion
2019-05-19
Completion
2019-06-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03986905 on ClinicalTrials.gov