Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion

Completed · Phase 3 · Has a placebo group

Conditions studied: Motion Sickness

In brief

This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating DPI-386 Nasal Gel versus placebo. Approximately 500 subjects will be randomized 1:1 (250 DPI 386 Nasal Gel/250 matching Placebo Nasal Gel) are planned to be enrolled.

Key facts

Study ID

NCT05548270

Run by

Repurposed Therapeutics, Inc.

People needed

503

Starts

2022-08-23

Expected to finish

2022-11-29

Last updated by the study team

2023-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability in the opinion of the Investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications.
• Male and female subjects ≥18 years of age.
• Susceptible to provocative motion as evidenced by at least three responses of "Frequently" from the Motion Sickness Susceptibility Questionnaire Short-Form (MSSQ-Short).
• Acceptable overall medical condition to be safely enrolled in and complete the study in the opinion of the Investigator.
• Ability to take intranasal medication.
• Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is 2 years postmenopausal), or females of child-bearing potential using an acceptable method of birth control (i.e., oral contraception, systemic [injectable or patch] contraception, double barrier methods, strict abstinence, condoms, diaphragm, spermicidal agents, cervical cap, copper intrauterine device, etc.) for a period of up to 30 days before dosing and for one month after dosing and must have a negative pregnancy test at screening.
• Agree to adhere to the following lifestyle compliance considerations:
• Refrain from consumption of grapefruit and any substance containing grapefruit for 7 days prior to, during, and 7 days after study drug administration;
• Abstain from alcohol for 24 hours prior to the administration of study drug and throughout the ocean travel;
• Abstain from marijuana within the 7-day period prior to the Treatment Day and throughout Day 2.
• Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-COV-2) negative test, confirmed by Food and Drug Administration (FDA) authorized COVID-19 test ≤ 7 days prior to study drug administration or no COVID 19 symptoms 10 days prior to study drug administration.

You may not qualify if…

• Nauseated prior to boarding.
• Mini-Mental State Examination score of <24.
• Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential, who:
• Are or intend to become pregnant (including use of fertility drugs) during the study;
• Are nursing (female subjects only);
• Are not using an acceptable, highly effective method of contraception until all follow up procedures are complete.
• Known allergic reactions to scopolamine or other anticholinergics.
• Hospitalization or significant surgery requiring hospital admittance within the past 6 months.
• Treatment with another investigational product within the past 30 days.
• Donated blood or plasma or suffered significant blood loss within the past 30 days.
• Chronic nausea caused by conditions such as irritable bowel syndrome, gastroparesis, cyclic vomiting syndrome or any other cause.
• Having any of the following medical conditions within the last 2 years or if any of the following medical conditions were experienced more than 2 years ago and are deemed as clinically significant by the Investigator:
• Significant gastrointestinal disorder, asthma, or seizure disorders;
• History of or current cardiovascular disease;
• History of or current vestibular disorders;
• History of or current narrow-angle glaucoma;
• History of or current urinary retention problems; or
• History of or current alcohol or drug abuse.
• Has had any prior nasal, nasal sinus, or nasal mucosa surgery.
• Currently taking any of the following medication types within the specified washout period:
• Any form of scopolamine (including Transderm Scop®/washout 5 days;
• Belladonna alkaloids/washout 14 days;
• Antihistamines (including meclizine/washout 14 days;
• Tricyclic antidepressants/washout 14 days;
• Muscle relaxants/washout 4 days; or

Where it is running

• Santa Monica Clinical Trials — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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