A Phase 3 interventional study of Tradipitant and Placebo in Motion Sickness, sponsored by Vanda Pharmaceuticals. Completed at 7 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment
A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's enrollment of 366 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tradipitant
Drug: Tradipitant
Drug: Placebo
Oral Capsule
Oral Capsule
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
| Milestone | Tradipitant High Dose | Tradipitant Low Dose | Placebo |
|---|---|---|---|
| Started | 121 | 123 | 122 |
| Completed | 120 | 123 | 122 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
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.
| Participants | Tradipitant High Dose | Tradipitant Low Dose | Placebo |
|---|---|---|---|
| Prevention of Vomiting Measured by Vomiting Assessment (VA) | 22 | 24 | 54 |
Collected over Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tradipitant High Dose | 0/120 (0%) | 0/120 (0%) | 26/120 (21.7%) |
| Tradipitant Low Dose | 0/123 (0%) | 0/123 (0%) | 20/123 (16.3%) |
| Placebo | 0/122 (0%) | 0/122 (0%) | 4/122 (3.3%) |
| Event | Tradipitant High Dose | Tradipitant Low Dose | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 10/120 | 7/123 | 3/122 |
| SomnolenceNervous system disorders | 10/120 | 8/123 | 1/122 |
| FatigueGeneral disorders | 10/120 | 5/123 | 0/122 |
| Age, Continuous(years) | Tradipitant High Dose | Tradipitant Low Dose | Placebo | Total |
|---|---|---|---|---|
| Mean | 47.7 ± 14.84 | 49.6 ± 14.40 | 48.6 ± 13.48 | 48.6 ± 14.23 |
| Sex: Female, Male(Participants) | Tradipitant High Dose | Tradipitant Low Dose | Placebo | Total |
|---|---|---|---|---|
| Female | 87 | 82 | 75 | 244 |
| Male | 34 | 41 | 47 | 122 |
| Ethnicity (NIH/OMB)(Participants) | Tradipitant High Dose | Tradipitant Low Dose | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 14 | 12 | 14 | 40 |
| Not Hispanic or Latino | 99 | 102 | 105 | 306 |
| Unknown or Not Reported | 8 | 9 | 3 | 20 |
| Race/Ethnicity, Customized(Participants) | Tradipitant High Dose | Tradipitant Low Dose | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 2 | 3 |
| Asian | 7 | 9 | 11 | 27 |
| Black or African American | 10 | 5 | 5 | 20 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| White | 103 | 105 | 102 | 310 |
| Other | 0 | 3 | 2 | 5 |
| Region of Enrollment(participants) | Tradipitant High Dose | Tradipitant Low Dose | Placebo | Total |
|---|---|---|---|---|
| United States | 121 | 123 | 122 | 366 |
| Body Mass Index (BMI)(kg/m^2) | Tradipitant High Dose | Tradipitant Low Dose | Placebo | Total |
|---|---|---|---|---|
| Mean | 26.785 ± 4.6327 | 27.299 ± 4.9265 | 28.037 ± 5.1835 | 27.377 ± 4.9342 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tradipitant