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

NCT05548270 | Completed Phase 3 FDA Drug

• 1 other identifier: DPI-386-MS-33
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Motion Sickness

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Report no Vomiting Within 4 Hours or to end of voyage, whichever comes later after Receiving Study Drug and no Use of Rescue Treatment

  Proportion of subjects who report no vomiting within 4 hours or to end of voyage, whichever comes later, after receiving study drug and no use of rescue treatment (e.g., antihistamine) within 4 hours or to end of voyage, whichever comes later, after receiving study drug (Complete Responders).

  4 hours

Secondary Outcomes (3)

• Time to vomiting or use of rescue medication

  4 hours

• Proportion of subjects who did not have moderate or severe nausea, which is defined as those subjects who report no moderate and severe nausea within 4 hours after receiving study drug and who did not use rescue treatment

  4 hours

• Proportion of subjects who did not have nausea, which is defined as those subjects who report no nausea within 4 hours after receiving study drug and who did not use rescue treatment

  4 hours

Study Arms (2)

DPI-386

EXPERIMENTAL

Each 0.12 gram of the gel contains0.2 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

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 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 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;

Sponsors & Collaborators

• Repurposed Therapeutics, Inc.: lead

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: August 23, 2022
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)