ClinicalTrials.gg
Status unknownNCT03920644INSCOPUpdated Apr 19, 2019

Study of the Safety and Efficacy of DPI-386 Nasal Gel on Ocean-Going Vessels

A Phase 3 interventional study of Scopolamine Transdermal Patch [Transderm Scop] and Scopolamine in Prevention of Nausea Associated With Motion Sickness and Treatment of Nausea Associated With Motion Sickness, sponsored by Naval Aeromedical Research Unit, Dayton. Status unknown at 1 site in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by Naval Aeromedical Research Unit, Dayton · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify the safety and efficacy of DPI 386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated with motion sickness. The study will be conducted aboard military ships undergoing military operations or aboard commercial boats rented for the study to obtain data in a real world environment. The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.0 mg/72 hours; transdermal scopolamine patch [TDS], the current standard of care for the treatment of motion sickness). The study will include 120 subjects per arm, for a total of 360 subjects (n=360). A double-dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or TDS patch + placebo nasal gel.

02

Conditions studied

  • Prevention of Nausea Associated With Motion Sickness
  • Treatment of Nausea Associated With Motion Sickness

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Keywords

  • Motion Sickness, INSCOP, Scopolamine, Defender, NAMRU
03

In context

Motion Sickness

50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.

This study's planned enrollment of 320 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.

Browse Motion Sickness studies →

Lead sponsor

This is the only study on the registry with Naval Aeromedical Research Unit, Dayton as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Provision of signed and dated document (ICD). 2. Stated willingness to comply with all study procedures and availability for the duration of the study.

      1. Male or female, aged 18 to 59 (inclusive). 4. Tricare health insurance beneficiary. All potential subjects must be able to provide a current military Identification (ID) or Department of Defense (DOD) dependent ID to be viewed by the research staff prior to signing the ICD.
      1. At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the MSSQ.
      1. In good general health as evidenced by medical history with no recent history or current diagnosis of clinical problems as assessed by the research staff.
      1. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
      1. For females of : willingness to provide a urine sample for the hCG pregnancy test during the Screening Visit and each day of the Treatment Period. Test must be negative or the subject will be excluded from the study. Note: Women of non-childbearing potential are defined as those who are non-surgically sterile (i.e., without menses for at least 12 consecutive months) or surgically sterile (i.e., those who underwent a hysterectomy with or without oophorectomy, fallopian tube ligation, and endometrial ablation).
      1. Agreement to adhere to the following lifestyle compliance considerations:
      2. Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the Treatment Period.
      3. Abstain from alcohol for 24 hours prior to first dose of study medication and during the Treatment Period.
      4. Note: there will be no restriction on caffeine or nicotine use during the study; however, the actual use of these substances will be recorded as part of the CEBQ.

Exclusion criteria

Exclusion Criteria:

    1. Pregnancy, lactation, or positive urine pregnancy test at any time. 2. Known allergic reactions to any drugs. 3. Currently prescribed any of the following medication types: any form of scopolamine (including Transderm Scop®) within 5 days, belladonna alkaloids within 2 weeks, antihistamines (including meclizine) within 2 weeks, tricyclic antidepressants within 2 weeks (depending on reason taken), muscle relaxants and nasal decongestant within 4 days of Module 1.

      1. Hospitalization or significant medical event (to include childbirth) within the past six months.
      1. Treatment with another drug or other intervention within the past 30 days.
      1. Having donated blood or plasma or suffered significant blood loss within the past 30 days.
      1. Having any of the following medical conditions within the last two years or if any of the following medical conditions were experienced more than two years ago and are deemed by the PI or Study Physician:
      2. Any known drug allergies and/or severe year-round environmental allergies.
      3. Significant gastrointestinal disorder, asthma, or seizure disorders.
      4. History of vestibular disorders.
      5. History of narrow-angle glaucoma.
      6. History of urinary retention problems.
      7. History of alcohol or drug abuse.
      8. Nasal, nasal sinus, or nasal mucosa surgery.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    DPI-386 Nasal Gel

    Receives Active Nasal Gel 2 times per treatment day

    Drug: Scopolamine · Drug: Placebo Patch

  • Placebo comparator
    Placebo nasal gel

    Receives Nasal Gel 2 times per treatment day

    Drug: Placebo Patch · Drug: Placebo Gel

  • Active comparator
    TDS Patch

    Receives one patch per treatment.

    Drug: Scopolamine Transdermal Patch [Transderm Scop] · Drug: Placebo Gel

Interventions

  • Current Motion Sickness treatment, 1 patch behind the ear.

    Also known as: TDS, Patch

  • IND, up to 6 administration of intranasal gel.

    Also known as: DPI-386

  • DrugPlacebo Patch

    Placebo Patch, 1 patch behind the ear.

  • DrugPlacebo Gel

    Placebo Gel,up to 6 administration of intranasal gel.

06

What researchers measure

Primary outcomes

  1. Determine the efficacy of DPI-386 nasal gel compared to 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)(scale 1-10) scores over the treatment period across all three treatment arms

    Time frame: Through study completion, an average of 1 year

  2. Determine the safety of DPI-386 Nasal Gel compared to the TDS patch and placebo nasal gel with an emphasis on cognitive effects.

    the safety endpoint is the incidence of adverse events.

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Determine the efficacy of DPI-386 Nasal Gel compared to the TDS patch and the placebo nasal gel in severity of nausea.

    Severity of nausea will measured by the Nausea Assessment (VAS)(scale 1-9) over the treatment period.

    Time frame: Through study completion, an average of 1 year

  2. Determine the safety of DPI-386 Nasal Gel as compared to the TDS patch and placebo nasal gel in terms of cognition.

    Safety in terms of cognition will be measured by Computer task.

    Time frame: Through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2019; primary completion for Nov 2019, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2019
First posted
Apr 19, 2019
StartEst.
Apr 2019
Primary completionEst.
Nov 2019
CompletionEst.
Mar 2021
Last update
Apr 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03920644
Lead sponsor
Naval Aeromedical Research Unit, Dayton
Responsible party
Matthew Doubrava (Senior Medical Officer, Aeromedical department Head, Naval Aeromedical Research Unit, Dayton) — Principal investigator
First posted
Apr 19, 2019
Start date
Apr 2019 (estimated)
Primary completion
Nov 2019 (estimated)
Completion
Mar 2021 (estimated)
Last update
Apr 19, 2019

Study contacts

Joshua Baker, MS
Contact
Joshua.baker.16.ctr@us.af.mil
9376562473
Jackie Gomez, BS
Contact
jacqueline.gomez.3.ctr@us.af.mil
937-938-3923

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Scopolamine

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