Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects (NCT03988530) | Clinical Trial Compass
CompletedPhase 3
Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects
United States98 participantsStarted 2019-06-07
Plain-language summary
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI 386 Nasal Gel for the Prevention and Treatment of Nausea Associated with Motion Sickness in Senior Subjects With Open-Label Follow-Up
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of a signed and dated Informed Consent Form (ICF).
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Male or female, aged 55 and over.
. In good general health as evidenced by medical history with no recent history or current diagnosis of uncontrolled clinical problems as assessed by the Principal Investigator (PI) or qualified designee.
. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
. Agreement to adhere to the following lifestyle compliance considerations:
Exclusion criteria
. Known allergic reactions to scopolamine or other anticholinergics.
. Currently prescribed any of the following medication types and used within the specified washout periods below:
. Hospitalization or significant surgery requiring hospital admittance within the past six months.
. Treatment with another investigational drug or other intervention within the past 30 days.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication).
Timeframe: During voyage on Treatment Day 1.
2
Safety of DPI-386 Nasal Gel compared to placebo nasal gel with an emphasis on cognitive adverse events.
. 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 qualified designee: