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

NCT03988530 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-05-06

No results posted yet for this study

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

Conditions

Interventions

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.

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
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-07
Primary Completion
2020-11-23
Completion
2020-11-23
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 NCT03988530 on ClinicalTrials.gov