A Phase 3 interventional study of Scopolamine Transdermal Patch [Transderm Scop] and Scopolamine in Prevention of Nausea Associated With Motion Sickness and Treatment of Nausea Associated With Motion Sickness, sponsored by Naval Aeromedical Research Unit, Dayton. Status unknown at 1 site in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-19.
Sponsored by Naval Aeromedical Research Unit, Dayton · Phase 3, Interventional, and Treatment
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.
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's planned enrollment of 320 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →This is the only study on the registry with Naval Aeromedical Research Unit, Dayton as lead sponsor.
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Provision of signed and dated document (ICD). 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives Active Nasal Gel 2 times per treatment day
Drug: Scopolamine · Drug: Placebo Patch
Receives Nasal Gel 2 times per treatment day
Drug: Placebo Patch · Drug: Placebo Gel
Receives one patch per treatment.
Drug: Scopolamine Transdermal Patch [Transderm Scop] · Drug: Placebo Gel
Current Motion Sickness treatment, 1 patch behind the ear.
Also known as: TDS, Patch
IND, up to 6 administration of intranasal gel.
Also known as: DPI-386
Placebo Patch, 1 patch behind the ear.
Placebo Gel,up to 6 administration of intranasal gel.
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
Time frame: 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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Apr 2019; primary completion for Nov 2019, 7 months later.
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This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Scopolamine