A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion
Overview
- Phase
- Phase 3
- Intervention
- DPI-386 Nasal Gel
- Conditions
- Motion Sickness
- Sponsor
- Repurposed Therapeutics, Inc.
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Detailed Description
Eligible participants will be randomized 1:1 to DPI-386 Nasal Gel or matching placebo nasal gel and assigned a time and date for travel on an ocean vessel. Participants will be asked to self-administer the study medication while the ship is in harbor. The Modified Performance Self-Assessment Questionnaire (mPSAQ) will be completed by each participant prior to the administration of nasal gel, approximately every 30 minutes of travel, and at the end of travel. The participants will complete the Nausea Assessment Scale (NAS) every 30 minutes afer dosing, and at the end of travel. The participants will also be asked to complete a Sopite Assessment Questionnaire (SAQ) and a Patient Global Assessment of Severity (PGI-S) at 4 hours to describe their travel experience. All questionnaires will be submitted for analysis. An exit interview will also be conducted. The treatment phase will last approximately 4-5 hours
Investigators
Eligibility Criteria
Inclusion Criteria
- •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..
Exclusion Criteria
- •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;
Arms & Interventions
DPI-386 Nasal Gel
Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr
Intervention: DPI-386 Nasal Gel
Placebo
Placebo Nasal Gel (0.12 g)
Intervention: Placebo
Outcomes
Primary Outcomes
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).
Time Frame: 4 hours
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