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Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tradipitant | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tradipitant | Drug | Oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Most Severe Motion Sickness Severity During Vehicle Travel | As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement | 1 day |
| Percentage of Vomiting | Defined as subjects ever vomited (MSSS=6) or terminated early due to severity during the vehicle travel. As measured by the Motion Sickness Severity Scale (NRS 0-6). | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Santa Monica | California | 90404 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tradipitant | Tradipitant: Oral capsule |
| FG001 | Placebo | Placebo: Oral capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tradipitant | Tradipitant: Oral capsule |
| BG001 | Placebo | Placebo: Oral capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Most Severe Motion Sickness Severity During Vehicle Travel | As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement | Posted | Least Squares Mean | Standard Error | units on a scale | 1 day |
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|
All Adverse Events (AEs) were collected from the time of the subject's informed consent signature until the end of the subject's study participation. AEs reported or learned up to 7 days after the subject's last study visit or a new SAE(s) up to 30 days after last study visit were recorded. AEs were monitored for approximately one month after randomization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tradipitant | Tradipitant: Oral capsule | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Motion Sickness | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | Vanda Pharmaceuticals Inc. | 2027343400 | clinicaltrials@vandapharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2019 | Mar 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009041 | Motion Sickness |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
Oral capsule |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline BMI | Mean | Standard Deviation | kg/m^2 |
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| Primary | Percentage of Vomiting | Defined as subjects ever vomited (MSSS=6) or terminated early due to severity during the vehicle travel. As measured by the Motion Sickness Severity Scale (NRS 0-6). | Posted | Count of Participants | Participants | 1 day |
|
|
|
| 63 |
| 0 |
| 63 |
| 39 |
| 63 |
| EG001 | Placebo | Placebo: Oral capsule | 0 | 63 | 0 | 63 | 39 | 63 |
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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