MedTrace Logo

Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness

NCT04184115 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2019-12-03

No results posted yet for this study

Summary

Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study 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.

Conditions

Interventions

DRUG

DPI-386 Nasal Gel

1.5 mg reservoir of scopolamine to be delivered over a 72-hour period

DRUG

Placebos

Placebo Nasal Gel and placebo patch

Sponsors & Collaborators

  • Repurposed Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David R 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
2019-06-09
Primary Completion
2019-06-11
Completion
2019-06-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04184115 on ClinicalTrials.gov