Study of the Safety and Efficacy of DPI-386 Nasal Gel on Ocean-Going Vessels
NCT ID: NCT03920644
Last Updated: 2019-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
320 participants
INTERVENTIONAL
2019-04-30
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DPI-386 Nasal Gel
Receives Active Nasal Gel 2 times per treatment day
Scopolamine
IND, up to 6 administration of intranasal gel.
Placebo Patch
Placebo Patch, 1 patch behind the ear.
Placebo nasal gel
Receives Nasal Gel 2 times per treatment day
Placebo Patch
Placebo Patch, 1 patch behind the ear.
Placebo Gel
Placebo Gel,up to 6 administration of intranasal gel.
TDS Patch
Receives one patch per treatment.
Scopolamine Transdermal Patch [Transderm Scop]
Current Motion Sickness treatment, 1 patch behind the ear.
Placebo Gel
Placebo Gel,up to 6 administration of intranasal gel.
Interventions
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Scopolamine Transdermal Patch [Transderm Scop]
Current Motion Sickness treatment, 1 patch behind the ear.
Scopolamine
IND, up to 6 administration of intranasal gel.
Placebo Patch
Placebo Patch, 1 patch behind the ear.
Placebo Gel
Placebo Gel,up to 6 administration of intranasal gel.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
59 Years
ALL
Yes
Sponsors
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Naval Aeromedical Research Unit, Dayton
FED
Responsible Party
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Matthew Doubrava
Senior Medical Officer, Aeromedical department Head
Locations
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NAMRU Dayton
Dayton, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NAMRUD.2018.0002 Field Trial
Identifier Type: -
Identifier Source: org_study_id
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