Status:
UNKNOWN
Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness
Lead Sponsor:
Repurposed Therapeutics, Inc.
Conditions:
Motion Sickness
Eligibility:
All Genders
18-59 years
Phase:
PHASE3
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-38...
Detailed Description
The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.5 mg/72 hours; transdermal scopolamine patch \[TDS\], the current standard of care for the treatment of mot...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Having any of the following medical conditions within the last two years or deemed clinically significant by the PI or qualified designee as being exclusionary:
- 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.
Key Trial Info
Start Date :
April 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04272255
Start Date
April 22 2019
End Date
July 1 2020
Last Update
February 17 2020
Active Locations (1)
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1
NAMRU-D
Dayton, Ohio, United States, 45433