Motion Sickness
Conditions
Brief summary
A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel
Interventions
DRUGTradipitant
Oral Capsule
DRUGPlacebo
Oral Capsule
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* History of motion sickness * Age 18-75
Exclusion criteria
* Nausea-inducing disorder other than motion sickness * BMI\>40 * History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Vomiting Measured by Vomiting Assessment (VA) | 1 day | Prevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tradipitant High Dose Tradipitant: Oral Capsule | 121 |
| Tradipitant Low Dose Tradipitant: Oral Capsule | 123 |
| Placebo Placebo: Oral Capsule | 122 |
| Total | 366 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Tradipitant High Dose | Tradipitant Low Dose | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 47.7 years STANDARD_DEVIATION 14.84 | 49.6 years STANDARD_DEVIATION 14.4 | 48.6 years STANDARD_DEVIATION 13.48 | 48.6 years STANDARD_DEVIATION 14.23 |
| Body Mass Index (BMI) | 26.785 kg/m^2 STANDARD_DEVIATION 4.6327 | 27.299 kg/m^2 STANDARD_DEVIATION 4.9265 | 28.037 kg/m^2 STANDARD_DEVIATION 5.1835 | 27.377 kg/m^2 STANDARD_DEVIATION 4.9342 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 12 Participants | 14 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 102 Participants | 105 Participants | 306 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 9 Participants | 3 Participants | 20 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 9 Participants | 11 Participants | 27 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 5 Participants | 5 Participants | 20 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 103 Participants | 105 Participants | 102 Participants | 310 Participants |
| Region of Enrollment United States | 121 participants | 123 participants | 122 participants | 366 participants |
| Sex: Female, Male Female | 87 Participants | 82 Participants | 75 Participants | 244 Participants |
| Sex: Female, Male Male | 34 Participants | 41 Participants | 47 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 123 | 0 / 122 |
| other Total, other adverse events | 26 / 120 | 20 / 123 | 4 / 122 |
| serious Total, serious adverse events | 0 / 120 | 0 / 123 | 0 / 122 |
Outcome results
Primary
Prevention of Vomiting Measured by Vomiting Assessment (VA)
Prevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tradipitant High Dose | Prevention of Vomiting Measured by Vomiting Assessment (VA) | 22 Participants |
| Tradipitant Low Dose | Prevention of Vomiting Measured by Vomiting Assessment (VA) | 24 Participants |
| Placebo | Prevention of Vomiting Measured by Vomiting Assessment (VA) | 54 Participants |