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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 is a Phase 3 study that has completed, run by Repurposed Therapeutics. The registered enrollment target is 300 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03986905
The ClinicalTrials.gov registry entry for NCT03986905 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repurposed Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03986905 reports 0 study locations.
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.
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