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DPI 386 Nasal Gel for the Prevention of Nausea Associated With Motion Sickness

NCT04219982 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-01-07

No results posted yet for this study

Summary

Determine the efficacy, in terms of time to nausea (inclination to vomit), of DPI-386 Nasal Gel as compared to the current standard of care (TDS) and placebo nasal gel. • Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel (0.2 mg twice a day for six consecutive days) as compared to the current standard of care (TDS). Determine the safety of a multi-dose schedule of DPI-386 Nasal Gel with an emphasis on cognitive adverse events as compared to the current standard of care (TDS) and placebo nasal gel. Determine how alertness is affected by administration of DPI-386 Nasal Gel, as compared to the current standard of care (TDS) and placebo nasal gel.

Conditions

Interventions

DRUG

DPI-386 Nasal Gel

Nasal gel

DRUG

DPI-386 Placebo Nasal Gel

DPI-386 Placebo Nasal Gel

DRUG

Transderm Scop®

Transderm Scop®

Sponsors & Collaborators

  • Repurposed Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Helton · Repurposed Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-06-29
Primary Completion
2019-01-28
Completion
2019-01-28
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 NCT04219982 on ClinicalTrials.gov