ClinicalTrials.gg
CompletedNCT04947423Updated Sep 17, 2021

Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion

A Phase 3 interventional study of DPI-386 Nasal Gel and Placebo in Motion Sickness, sponsored by Repurposed Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-17.

Sponsored by Repurposed Therapeutics, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2021, 5 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a Phase 3, two-arm, randomized, double-blind, placebo-controlled, single dose efficacy and safety study evaluating the use of a nasal gel to prevent nausea and vomiting associated with motion

Read the detailed description

Eligible participants will be randomized 1:1 to DPI-386 Nasal Gel or matching placebo nasal gel and assigned a time and date for travel on an ocean vessel. Participants will be asked to self-administer the study medication while the ship is in harbor. The Modified Performance Self-Assessment Questionnaire (mPSAQ) will be completed by each participant prior to the administration of nasal gel, approximately every 30 minutes of travel, and at the end of travel. The participants will complete the Nausea Assessment Scale (NAS) every 30 minutes afer dosing, and at the end of travel. The participants will also be asked to complete a Sopite Assessment Questionnaire (SAQ) and a Patient Global Assessment of Severity (PGI-S) at 4 hours to describe their travel experience. All questionnaires will be submitted for analysis. An exit interview will also be conducted.

The treatment phase will last approximately 4-5 hours

02

Conditions studied

  • Motion Sickness

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03

In context

Motion Sickness

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

This study's enrollment of 140 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.

Browse Motion Sickness studies →

Lead sponsor

Repurposed Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 70 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. Ability to provide written, prior to initiation of any study-related procedures, and ability in the opinion of the Investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications.
  2. Male and female participants, aged 18 to 70 years of age (inclusive);
  3. Minimally susceptible to provocative motion as evidenced by at least two responses on the (MSSQ-short) of "Sometimes" or "Frequently";
  4. Acceptable overall medical condition to be safely enrolled in and complete the study in the opinion of the Investigator;
  5. Ability to take intranasal medication;
  6. Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or participant is 2 years ), or females of using an acceptable method of (i.e., condoms, diaphragm, spermicidal agents, cervical cap, copper intrauterine device, etc.) for a period of up to 30 days before dosing and for one month after dosing and must have a negative pregnancy test at screening;
  7. Agree to adhere to the following lifestyle compliance considerations:

    1. Refrain from consumption of grapefruit and any substance containing grapefruit for 7 days prior to, during, and 7 days after study drug administration;
    2. Abstain from alcohol for 24 hours prior to the administration of study drug and through the ocean travel;
    3. Abstain from marijuana within the 7-day period prior to the Treatment Day and throughout Day 3..
  8. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) negative test, confirmed by Food and Drug Administration (FDA) authorized COVID-19 test \< 7 days prior to study drug administration or no COVID 19 symptoms up to 10 days prior to study drug administration.

Exclusion criteria

Exclusion Criteria:

Main Criteria for Exclusion:

  1. Nauseated prior to boarding.
  2. score of \<24;
  3. Women of , or men whose sexual partner(s) is a woman of childbearing potential, who:

    1. Are or intend to become pregnant (including use of fertility drugs) during the study;
    2. Are nursing (female participants only);
    3. Are not using an acceptable, highly effective method of until all follow-up procedures are complete.
  4. Known allergic reactions to scopolamine or other anticholinergics;
  5. Hospitalization or significant surgery requiring hospital admittance within the past 6 months;
  6. Treatment with another product within the past 30 days;
  7. Donated blood or plasma or suffered significant blood loss within the past 30 days;
  8. Chronic nausea caused by conditions such as irritable bowel syndrome, gastroparesis, cyclic vomiting syndrome or any other cause;
  9. Having any of the following medical conditions within the last 2 years or if any of the following medical conditions were experienced more than 2 years ago and are deemed as by the Investigator:

    1. Significant gastrointestinal disorder, asthma, or seizure disorders;
    2. History or current cardiovascular disease;
    3. History or current vestibular disorders;
    4. History or current narrow-angle glaucoma;
    5. History or current urinary retention problems;
    6. History or current alcohol or drug abuse;
    7. History or current nasal, nasal sinus or nasal mucosa surgery.
  10. Currently taking any of the following medication types within the specified :

    1. Any form of scopolamine (including Transderm Scop®/washout 5 days;
    2. Belladonna alkaloids/washout 14 days;
    3. Antihistamines (including meclizine/washout 14 days;
    4. Tricyclic antidepressants/washout 14 days;
    5. Muscle relaxants/washout 4 days, and;
    6. Nasal decongestants/washout 4 days.
  11. Has used marijuana within the 7-day period prior to the Treatment Day. (Note: this criterion will only be confirmed at Eligibility Confirmation, not at Recruitment and Screening, although heavy users of marijuana can be determined ineligible at Screening. All potential study participants deemed eligible at Screening must be informed at that time that this requirement must be met at Eligibility Confirmation.)
  12. Unwilling or unable to follow the medication restrictions or unwilling to wash-out the use of restricted medications as noted in Exclusion 10.
Terms in these criteria, in plain language(8)

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

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.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

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.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    DPI-386 Nasal Gel

    Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr

    Drug: DPI-386 Nasal Gel

  • Placebo comparator
    Placebo

    Placebo Nasal Gel (0.12 g)

    Drug: Placebo

Interventions

  • Subjects will self-administer DPI-386 Nasal Gel or Placebo

    Also known as: scopolamine

  • DrugPlacebo

    Subjects will self-administer DPI-386 Nasal Gel or Placebo

06

What researchers measure

Primary outcomes

  1. Proportion of participants who report no vomiting within 4 hours after receiving study drug and no use of rescue treatment (e.g., dimenhydrinate) within 4 hours after receiving study drug (Complete Responders).

    Participants who report no vomiting within 4 hours after receiving study drug and no use of rescue treatment (e.g., dimenhydrinate) within 4 hours after receiving study drug

    Time frame: 4 hours

07

Study locations

1 site
  • Santa Monica Clinical Trials
    Santa Monica, California 90404, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04947423
Lead sponsor
Repurposed Therapeutics, Inc.
Collaborators
Defender Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jul 1, 2021
Start date
Jun 14, 2021
Primary completion
Aug 12, 2021
Completion
Aug 12, 2021
Last update
Sep 17, 2021

Study contacts

David Helton
study director · Defender Pharmaceuticals, Inc.

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 completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: DPI-386

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