Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness

NCT04272255 | Unknown Phase 3 FDA Drug

• 1 other identifier: DPI-386-MS-08
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled and open label active-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 motion sickness. The study will be conducted aboard Navy fleet or Marine ships undergoing military operations to obtain data in an operationally relevant real world environment.

Conditions

Motion Sickness

Outcome Measures

Primary Outcomes (2)

• Efficacy of DPI-386 Nasal Gel

  Compare the efficacy of DPI-386 Nasal Gel (0.2 mg scopolamine HBr per dose, maximum of two doses per day, for a maximum of six doses over three consecutive days) with that of the TDS patch and placebo nasal gel in the prevention and treatment of nausea associated with motion sickness. The efficacy endpoint will be determined by comparing the Motion Sickness Assessment Questionnaire (MSAQ) scores over the treatment period across all three treatment arm. Sixteen symptoms are listed, with symptoms differentiated along four dimensions: gastrointestinal, central, peripheral, and sopite-related. Each symptom is scored from 1 to 9 in severity and scores then calculated. All 16 items were collected from the general public instead of experts, allowing for a more accurate wording of the symptomology experienced by persons outside of hysiological sciences.

  3 days

• Safety of DPI-386 Nasal Gel in terms of cognitive effects

  Compare the safety of DPI-386 Nasal Gel with that of the TDS patch and placebo nasal gel, with an emphasis on cognitive effects by incidence of treatment related adverse events.

  24 hours

Secondary Outcomes (2)

• Efficacy of DPI-386 and severe nausea

  3 days

• Safety of DPI-386 Nasal Gel in terms of cognition

  24 hours

Study Arms (3)

DPI-386 nasal gel

ACTIVE COMPARATOR

DPI-386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.1 g dose, with each dose therefore described as "0.2 mg / 0.1 g"

Drug: scopolamine HBr

placebo nasal gel

PLACEBO COMPARATOR

Placebo nasal gel product is the same but does not contain scopolamine HBr

Drug: scopolamine HBr

Transderm Scop®

EXPERIMENTAL

TDS patch delivers 1.5 mg of scopolamine over a 72-hour period. TDS arm will apply two TDS patches over the six treatment days.

Drug: Transdermal Scopolamine

Interventions

scopolamine HBr DRUG

Nasal Gel

DPI-386 nasal gel; placebo nasal gel

Transdermal Scopolamine DRUG

Patch

Transderm Scop®

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated ICD.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18 to 59 (inclusive).
• Active duty military or reserves on active status. All potential subjects must be able to provide a current military ID to be viewed by PI or qualified designee prior to signing the ICD.
• At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the Motion Sickness Susceptibility Questionnaire (MSSQ).
• In good general health as evidenced by medical history with no recent history or current diagnosis of clinical problems as recommended by the PI or qualified designee.
• Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
• For females of child-bearing potential: willingness to provide a urine sample for the hCG pregnancy test. Test must be negative.
• Agreement to adhere to the following lifestyle compliance considerations:
• Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the six treatment days.
• Abstain from alcohol for 24 hours prior to first dose of study medication and during the six Treatment Days.

You may not qualify if:

• Pregnancy, lactation, or positive urine pregnancy test at screening.
• Known allergic reactions to scopolamine or other anticholinergics.
• Currently prescribed any of the following medication types: belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants.
• Hospitalization or significant surgery requiring hospital admittance within the past six months.
• Treatment with another investigational drug or other intervention within the past 30 days.
• Having donated blood or plasma or suffered significant blood loss within the past 30 days.
• Significant gastrointestinal disorder, asthma, or seizure disorders.
• History of vestibular disorders.
• History of narrow-angle glaucoma.
• History of urinary retention problems.
• History of alcohol or drug abuse.
• Nasal, nasal sinus, or nasal mucosa surgery.

Sponsors & Collaborators

• Repurposed Therapeutics, Inc.: lead

Study Sites (1)

NAMRU-D

Dayton, Ohio, 45433, United States

RECRUITING

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Helton

  Repurposed Therapuetics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: February 17, 2020
• Study Start: April 22, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

US (1)