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

April 17, 2019 updated by: Matthew Doubrava, Naval Aeromedical Research Unit, Dayton

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of Defender Pharmaceuticals Inc, (DPI)-386 Nasal Gel on Ocean-Going Vessels for the Prevention and Treatment of Nausea Associated With Motion Sickness

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 57 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

    3. 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.

    5. At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the MSSQ.

    6. 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.

    7. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.

    8. For females of child-bearing potential: 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).

    9. Agreement to adhere to the following lifestyle compliance considerations:

    1. Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the Treatment Period.
    2. Abstain from alcohol for 24 hours prior to first dose of study medication and during the Treatment Period.

    3. 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:

  • 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.

    4. Hospitalization or significant medical event (to include childbirth) within the past six months.

    5. Treatment with another investigational drug or other intervention within the past 30 days.

    6. Having donated blood or plasma or suffered significant blood loss within the past 30 days.

    7. 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 clinically significant by the PI or Study Physician:

    1. Any known drug allergies and/or severe year-round environmental allergies.
    2. Significant gastrointestinal disorder, asthma, or seizure disorders.
    3. History of vestibular disorders.
    4. History of narrow-angle glaucoma.
    5. History of urinary retention problems.
    6. History of alcohol or drug abuse.
    7. Nasal, nasal sinus, or nasal mucosa surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DPI-386 Nasal Gel
Receives Active Nasal Gel 2 times per treatment day
Drug: Scopolamine
IND, up to 6 administration of intranasal gel.
Other Names:
  • DPI-386
Drug: Placebo Patch
Placebo Patch, 1 patch behind the ear.
Placebo Comparator: Placebo nasal gel
Receives Nasal Gel 2 times per treatment day
Drug: Placebo Patch
Placebo Patch, 1 patch behind the ear.
Drug: Placebo Gel
Placebo Gel,up to 6 administration of intranasal gel.
Active Comparator: TDS Patch
Receives one patch per treatment.
Drug: Placebo Gel
Placebo Gel,up to 6 administration of intranasal gel.
Drug: Scopolamine Transdermal Patch [Transderm Scop]
Current Motion Sickness treatment, 1 patch behind the ear.
Other Names:
  • TDS, Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through study completion, an average of 1 year
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
Through study completion, an average of 1 year
Determine the safety of DPI-386 Nasal Gel compared to the TDS patch and placebo nasal gel with an emphasis on cognitive effects.
Time Frame: Through study completion, an average of 1 year
the safety endpoint is the incidence of adverse events.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the efficacy of DPI-386 Nasal Gel compared to the TDS patch and the placebo nasal gel in severity of nausea.
Time Frame: Through study completion, an average of 1 year
Severity of nausea will measured by the Nausea Assessment (VAS)(scale 1-9) over the treatment period.
Through study completion, an average of 1 year
Determine the safety of DPI-386 Nasal Gel as compared to the TDS patch and placebo nasal gel in terms of cognition.
Time Frame: Through study completion, an average of 1 year
Safety in terms of cognition will be measured by Computer task.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Naval Aeromedical Research Unit, Dayton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAMRUD.2018.0002 Field Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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