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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920644
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Doubrava, Naval Aeromedical Research Unit, Dayton

Brief 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.

Condition or disease Intervention/treatment Phase
Prevention of Nausea Associated With Motion Sickness Treatment of Nausea Associated With Motion Sickness Drug: Scopolamine Transdermal Patch [Transderm Scop] Drug: Scopolamine Drug: Placebo Patch Drug: Placebo Gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double Blinded
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Scopolamine

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 Name: 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: Scopolamine Transdermal Patch [Transderm Scop]
Current Motion Sickness treatment, 1 patch behind the ear.
Other Name: TDS, Patch

Drug: Placebo Gel
Placebo Gel,up to 6 administration of intranasal gel.




Primary Outcome Measures :
  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. [ 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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920644


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

Locations
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United States, Ohio
NAMRU Dayton Recruiting
Dayton, Ohio, United States, 45433
Contact: Joshua Baker, MS    937-656-2473    Joshua.baker.16.ctr@uf.af.mil   
Contact: Jackie Gomez, BS    937-938-3923    jacqueline.gomez.3.ctr@us.af.mil   
Sub-Investigator: Leslie Drummond, Ph.D.         
Sponsors and Collaborators
Naval Aeromedical Research Unit, Dayton
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Responsible Party: Matthew Doubrava, Senior Medical Officer, Aeromedical department Head, Naval Aeromedical Research Unit, Dayton
ClinicalTrials.gov Identifier: NCT03920644    
Other Study ID Numbers: NAMRUD.2018.0002 Field Trial
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Doubrava, Naval Aeromedical Research Unit, Dayton:
Motion Sickness, INSCOP, Scopolamine, Defender, NAMRU
Additional relevant MeSH terms:
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Nausea
Motion Sickness
Signs and Symptoms, Digestive
Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics