drugset / Trial / NCT04219982
DPI 386 Nasal Gel for the Prevention of Nausea Associated With Motion Sickness
RandomizedSequentialTriple-blindPrevention
Summary
Determine the efficacy, in terms of time to nausea (inclination to vomit), of DPI-386 Nasal Gel as compared to the current standard of care (TDS) and placebo nasal gel. • Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel (0.2 mg twice a day for six consecutive days) as compared to the current standard of care (TDS). Determine the safety of a multi-dose schedule of DPI-386 Nasal Gel with an emphasis on cognitive adverse events as compared to the current standard of care (TDS) and placebo nasal gel. Determine how alertness is affected by administration of DPI-386 Nasal Gel, as compared to the current standard of care (TDS) and placebo nasal gel.
Timeline
- Start
- 2018-06-29
- Primary completion
- 2019-01-28
- Completion
- 2019-01-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Scopolamine | Unknown | 0.2 mg | Intranasal |
| Comparator | Scopolamine | Unknown | — | — |