Study of the Safety and Efficacy of DPI-386 Nasal Gel on Ocean-Going Vessels
INSCOP
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
1 other identifier
interventional
320
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedApril 19, 2019
April 1, 2019
7 months
April 3, 2019
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Determine the efficacy of DPI-386 Nasal Gel compared to the TDS patch and the placebo nasal gel in severity of nausea.
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.
Through study completion, an average of 1 year
Study Arms (3)
DPI-386 Nasal Gel
EXPERIMENTALReceives Active Nasal Gel 2 times per treatment day
Placebo nasal gel
PLACEBO COMPARATORReceives Nasal Gel 2 times per treatment day
TDS Patch
ACTIVE COMPARATORReceives one patch per treatment.
Interventions
Current Motion Sickness treatment, 1 patch behind the ear.
IND, up to 6 administration of intranasal gel.
Eligibility Criteria
You may qualify if:
- \. 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.
- \. 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.
- \. At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the MSSQ.
- \. 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.
- \. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
- \. 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).
- \. 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.
You may not qualify if:
- \. 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.
- \. Hospitalization or significant medical event (to include childbirth) within the past six months.
- \. Treatment with another investigational drug or other intervention within the past 30 days.
- \. Having donated blood or plasma or suffered significant blood loss within the past 30 days.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NAMRU Dayton
Dayton, Ohio, 45433, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double Blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Medical Officer, Aeromedical department Head
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 19, 2019
Study Start
April 1, 2019
Primary Completion
November 1, 2019
Study Completion
March 1, 2021
Last Updated
April 19, 2019
Record last verified: 2019-04