Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion

NCT04947423 | Completed Phase 3 FDA Drug

• 1 other identifier: DPI-386-MS-29
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Motion Sickness

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who report no vomiting within 4 hours after receiving study drug and no use of rescue treatment (e.g., dimenhydrinate) within 4 hours after receiving study drug (Complete Responders).

  Participants who report no vomiting within 4 hours after receiving study drug and no use of rescue treatment (e.g., dimenhydrinate) within 4 hours after receiving study drug

  4 hours

Study Arms (2)

DPI-386 Nasal Gel

EXPERIMENTAL

Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr

Drug: DPI-386 Nasal Gel

Placebo

PLACEBO COMPARATOR

Placebo Nasal Gel (0.12 g)

Drug: Placebo

Interventions

DPI-386 Nasal Gel DRUG

Subjects will self-administer DPI-386 Nasal Gel or Placebo

Also known as: scopolamine

DPI-386 Nasal Gel

Placebo DRUG

Subjects will self-administer DPI-386 Nasal Gel or Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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;

Sponsors & Collaborators

• Repurposed Therapeutics, Inc.: lead
• Defender Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Santa Monica Clinical Trials

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Motion Sickness

Interventions

Scopolamine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• David Helton

  Defender Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: June 14, 2021
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

US (1)