NCT05548270

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 503 (actual)
• Sponsor: Repurposed Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study (DPI-386-MS-33) is to prospectively evaluate the difference in the rate of complete response, defined as no vomiting and no rescue treatment (e.g., antihistamine) within the 4-hour period after study drug administration, or to the end of the voyage, whichever comes later, between 0.2 mg scopolamine administered as the DPI-386 Nasal Gel and Placebo Nasal Gel to subjects ≥18 years of age (inclusive) with a history of symptoms consistent with motion sickness (MS). The sample size of 250 subjects per treatment arm is considered sufficient to demonstrate a statistically significant difference between treatments.

Conditions

• Motion Sickness

Interventions

Type	Name	Description
DRUG	DPI-386 Nasal Gel	Subjects will self-administer DPI-386 Nasal Gel or Placebo
DRUG	Placebo	Subjects will self-administer DPI-386 Nasal Gel or Placebo

Timeline

• Start date: 2022-08-23
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2022-09-21
• Last updated: 2023-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study