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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prevention of Nausea Associated With Motion Sickness, Treatment of Nausea Associated With Motion Sickness

Intervention / Treatment
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* Drug: Scopolamine Transdermal Patch [Transderm Scop]
* Drug: Scopolamine
* Drug: Placebo Patch
* Drug: Placebo Gel


Participation Criteria
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Eligibility Criteria
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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: Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the Treatment Period. Abstain from alcohol for 24 hours prior to first dose of study medication and during the Treatment Period. 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: Any known drug allergies and/or severe year-round environmental allergies. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

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

What is the study measuring?
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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. | 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. | 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. | 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. | Safety in terms of cognition will be measured by Computer task. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motion Sickness, INSCOP, Scopolamine, Defender, NAMRU