CompletedPhase 3

Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects

United States98 participantsStarted 2019-06-07

Plain-language summary

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI 386 Nasal Gel for the Prevention and Treatment of Nausea Associated with Motion Sickness in Senior Subjects With Open-Label Follow-Up

Who can participate

Age range55 Years

SexALL

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Inclusion criteria

✓. Provision of a signed and dated Informed Consent Form (ICF).
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Male or female, aged 55 and over.
✓. In good general health as evidenced by medical history with no recent history or current diagnosis of uncontrolled clinical problems as assessed by the Principal Investigator (PI) or qualified designee.
✓. Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
✓. Agreement to adhere to the following lifestyle compliance considerations:

Exclusion criteria

✕. Known allergic reactions to scopolamine or other anticholinergics.
✕. Currently prescribed any of the following medication types and used within the specified washout periods below:
✕. Hospitalization or significant surgery requiring hospital admittance within the past six months.
✕. Treatment with another investigational drug or other intervention within the past 30 days.
✕. Having donated blood or plasma or suffered significant blood loss within the past 30 days.
✕. Having any of the following medical conditions within the last two years or if any of the following medical conditions were experienced more than two years ago and are deemed clinically significant by the PI or qualified designee:

What they're measuring

The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication).

Timeframe: During voyage on Treatment Day 1.

Safety of DPI-386 Nasal Gel compared to placebo nasal gel with an emphasis on cognitive adverse events.

Timeframe: During all four Treatment Days

Trial details

NCT IDNCT03988530

SponsorRepurposed Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-23

View on ClinicalTrials.gov More Motion Sickness trials