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, two-arm, randomized, double-blind, placebo-controlled, single dose efficacy and safety study evaluating the use of a nasal gel to prevent nausea and vomiting associated with motion

Key facts

Study ID

NCT04947423

Run by

Repurposed Therapeutics, Inc.

People needed

140

Starts

2021-06-14

Expected to finish

2021-08-12

Last updated by the study team

2021-09-17

Who can join

Age: 18 and older, up to 70. 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 participants, aged 18 to 70 years of age (inclusive);
• Minimally susceptible to provocative motion as evidenced by at least two responses on the (MSSQ-short) of "Sometimes" or "Frequently";
• 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 participant is 2 years postmenopausal), or females of childbearing potential using an acceptable method of birth control (i.e., 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 through the ocean travel;
• Abstain from marijuana within the 7-day period prior to the Treatment Day and throughout Day 3..
• 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 up to 10 days prior to study drug administration.

You may not qualify if…

• Main Criteria for Exclusion:
• 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 participants 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 or current cardiovascular disease;
• History or current vestibular disorders;
• History or current narrow-angle glaucoma;
• History or current urinary retention problems;
• History or current alcohol or drug abuse;
• History or current 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;

Where it is running

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

Full record on ClinicalTrials.gov

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