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Study of the Safety and Efficacy of DPI-386 Nasal Gel on Ocean-Going Vessels

NCT03920644 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2019-04-19

No results posted yet for this study

Summary

This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify the safety and efficacy 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 military ships undergoing military operations or aboard commercial boats rented for the study to obtain data in a real world environment. The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.0 mg/72 hours; transdermal scopolamine patch \[TDS\], the current standard of care for the treatment of motion sickness). The study will include 120 subjects per arm, for a total of 360 subjects (n=360). A double-dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or TDS patch + placebo nasal gel.

Conditions

  • Prevention of Nausea Associated With Motion Sickness
  • Treatment of Nausea Associated With Motion Sickness

Interventions

DRUG

Scopolamine Transdermal Patch [Transderm Scop]

Current Motion Sickness treatment, 1 patch behind the ear.

DRUG

Scopolamine

IND, up to 6 administration of intranasal gel.

DRUG

Placebo Patch

Placebo Patch, 1 patch behind the ear.

DRUG

Placebo Gel

Placebo Gel,up to 6 administration of intranasal gel.

Sponsors & Collaborators

  • Naval Aeromedical Research Unit, Dayton

    lead FED

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
2019-04-30
Primary Completion
2019-11-30
Completion
2021-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03920644 on ClinicalTrials.gov