Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03988530|
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Motion Sickness||Drug: Scopolamine Other: Placebo Nasal Gel||Phase 3|
This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study with open-label follow-up to identify the safety, efficacy and pharmacokinetics 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 have two arms: DPI-386 nasal gel and placebo nasal gel for Treatment Day 1. Treatment Day 1 will include 50 subjects per arm, for a total of 100 subjects (n=100). All 100 subjects from Treatment Day 1 will receive open-label DPI-386 Nasal Gel for Treatment Days 2-4 (50 of these were originally randomized to receive placebo prior to receipt of the investigational product.).
Treatment Day 1 will be conducted aboard an ocean-going vessel to obtain data in an operationally relevant real world environment and within 30 days of Treatment Day 1, Treatment Days 2-4 will take place at the clinical site.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||This study is double-blinded placebo controlled for all treatment arms on Treatment Day 1. All DPI-386 Nasal Gel and placebo nasal gel vials are opaque and indistinguishable. The DPI-386 Nasal Gel and placebo nasal gels are identical in color and viscosity, and without identifiable smell. Treatment Days 2-4 are open-label.|
|Official Title:||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|
|Actual Study Start Date :||May 31, 2019|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: DPI-386 Nasal Gel
DPI-386 Nasal Gel (0.2 mg / 0.12 g)
Subjects will self-administer DPI-386 Nasal Gel (0.2 mg / 0.12 g) or placebo nasal gel (0.12 g) on Treatment Day 1, and on Treatment Days 2 -4 all subjects will self administer DPI-386 Nasal Gel (0.2 mg / 0.12 g).
Other Name: DPI-386 Nasal Gel
Placebo Comparator: Placebo Nasal Gel
placebo nasal gel (0.12 g)
Other: Placebo Nasal Gel
Placebo Nasal Gel (0.12g) twice a day on Treatment Day 1.
- The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication). [ Time Frame: During voyage on Treatment Day 1. ]The efficacy endpoint is incidence of subjects who developed motion sickness and requested further treatment (i.e., subjects who received rescue medication) during an 8 hour voyage on Treatment Day 1.
- Safety of DPI-386 Nasal Gel compared to placebo nasal gel with an emphasis on cognitive adverse events. [ Time Frame: During all four Treatment Days ]Safety endpoint is the incidence of adverse events.
- Severity of nausea as measured by the Visual Analog Scale (VAS) over the treatment period. [ Time Frame: During Treatment Day 1 voyage. ]Respondents specify their degree of nausea by indicating a point along a continuous 100 mm line between two end-points; left one is for "No nausea" and the right one for "Very severe nausea". Scoring is based on the length from left point and a higher score means more severe degree of nausea (Spinks & Wasiak, 2011).
- Safety in terms of cognition as measured by the Psychomotor Vigilance Task (PVT). [ Time Frame: During Treatment Day 1 voyage ]The PVT is a neurocognitive assessment that measures alertness and tests sustained attention and reaction time. It was originally developed for sleep studies, and involves simple reaction time testing by requiring the participant to push a button as soon as the stimulus (a light) appears. After a response, the reaction time (in ms) is displayed. The inter-stimulus interval varies from two to 10 seconds, so it is not predictable, and the entire task takes 10 minutes (Dorrian, Rogers, & Dinges, 2005). There are also shorter versions which have been validated as reasonable substitutes for the 10 minute version, such as the five minute (Lamond, Dawson, & Roach, 2005)) and three minute versions (Grant, et al., (2017).
- Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel. [ Time Frame: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4. ]PK parameters to be measured by Maximum Observed Plasma Concentration (Cmax)
- Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel. [ Time Frame: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4. ]PK parameters to be measured by Time to Reach Maximum Observed Plasma Concentration (Tmax).
- Describe the pharmacokinetics (PK) of a multi-dose schedule of DPI-386 Nasal Gel. [ Time Frame: At time points -60, 30, 90, 120, 180, 330, 390, 450, 480 and 600 minutes during Treatment Days 2-4. ]PK parameters to be measured by Area Under the Curve (AUC)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988530
|Contact: Laurie Mellottfirstname.lastname@example.org|
|United States, California|
|Collaborative Neuroscience Network, LLC||Recruiting|
|Long Beach, California, United States, 90806|
|Contact: Jay Saifuki 562-304-1740|
|Study Director:||Daved R Helton||Repurposed Therapeutics|