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NCT03986905 · ClinicalTrials.gov registry record · Phase 3
The Prevention and Treatment of Nausea Associated With Motion Sickness
A Phase 3 study, sponsored by Repurposed Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT03986905: Completed Phase 3 study, sponsored by Repurposed Therapeutics.
NCT03986905 is a Phase 3 study that has completed, run by Repurposed Therapeutics. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03986905, a Phase 3 study, has completed, sponsored by Repurposed Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
This single-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify the safety and efficacy of a repeated-dose regimen of DPI 386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated with motion sickness. The study will be conducted aboard an ocean going vessel to obtain data in a real world environment. The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and TDS patch (1.5 mg/72 hours), the current standard of care for the treatment of motion sickness. The study will include 100 subjects per arm, for a total of 300 subjects (n=300). Multiple voyages with the same vessel will be used until the required enrollment is completed. A double dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel randomized to one of the following three arms: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, and placebo nasal gel + TDS patch.
Primary Outcome
The efficacy endpoint is incidence of subjects who developed motion sickness and request further treatment with Rescue medication during an 8 hour voyage on Treatment Day 1.
Interventions
- OTHER Placebo
- DRUG Scopolamine Nasal Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2019-04-26 |
| Est. Completion | 2019-06-19 |
| Phase | Phase 3 |
What the finished NCT03986905 record still lists
NCT03986905 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03986905 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03986905 about?
NCT03986905 is a clinical study titled "The Prevention and Treatment of Nausea Associated With Motion Sickness". This single-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify the safety and efficacy of a repeated-dose regimen of DPI 386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated with motion sickness. The study will ...
What is the current status of trial NCT03986905?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2019-04-26. Estimated completion is 2019-06-19.
What interventions are being tested in trial NCT03986905?
The interventions under investigation include: Placebo (OTHER), Scopolamine Nasal Gel (DRUG).
Who is sponsoring clinical trial NCT03986905?
This trial is sponsored by Repurposed Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03986905's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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