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This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with treatment-resistant pruritus diagnosed with atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tradipitant | Experimental | Oral |
|
| Placebo | Placebo Comparator | Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tradipitant | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score | Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm). | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Encinitas | California | 92024 | United States | ||
| Vanda Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tradipitant | Oral Tradipitant |
| FG001 | Placebo | Oral Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2017 | Mar 27, 2024 |
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|
| Encino |
| California |
| 91436 |
| United States |
| Vanda Investigational Site | Lomita | California | 90717 | United States |
| Vanda Investigational Site | San Diego | California | 92122 | United States |
| Vanda Investigational Site | San Diego | California | 92123 | United States |
| Vanda Investigational Site | Miami | Florida | 33126 | United States |
| Vanda Investigational Site | Miami | Florida | 33136 | United States |
| Vanda Investigational Site | Ormond Beach | Florida | 32174 | United States |
| Vanda Investigational Site | Columbus | Georgia | 31904 | United States |
| Vanda Investigational Site | Plainfield | Indiana | 46168 | United States |
| Vanda Investigational Site | Crowley | Louisiana | 70526 | United States |
| Vanda Investigational Site | St Louis | Missouri | 63110 | United States |
| Vanda Investigational Site | Las Vegas | Nevada | 89119 | United States |
| Vanda Investigational Site | New York | New York | 10022 | United States |
| Vanda Investigational Site | New York | New York | 10075 | United States |
| Vanda Investigational Site | High Point | North Carolina | 27262 | United States |
| Vanda Investigational Site | Wilmington | North Carolina | 28405 | United States |
| Vanda Investigational Site | Winston-Salem | North Carolina | 27104 | United States |
| Vanda Investigational Site | Portland | Oregon | 97239 | United States |
| Vanda Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Vanda Investigational Site | Johnston | Rhode Island | 02919 | United States |
| Vanda Investigational Site | Charleston | South Carolina | 29407 | United States |
| Vanda Investigational Site | Houston | Texas | 77030 | United States |
| Vanda Investigational Site | Pflugerville | Texas | 78660 | United States |
| Vanda Investigational Site | San Antonio | Texas | 78218 | United States |
| Vanda Investigational Site | West Jordan | Utah | 84088 | United States |
| Vanda Investigational Site | Seattle | Washington | 98101 | United States |
| Vanda Investigational Site | Spokane | Washington | 99202 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tradipitant | Oral Tradipitant |
| BG001 | Placebo | Oral Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Count of Participants | Participants |
| ||||||||||||||||
| Average Pruritus VAS at Baseline | Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm). | Mean | Standard Deviation | mm |
|
| 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 | Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score | Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm). | All participants randomized (1:1) to placebo or tradipitant. | Posted | Least Squares Mean | Standard Error | score on a scale | 56 days |
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All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 100 days) regardless of seriousness or relationship to investigational product.
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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 | Oral Tradipitant | 0 | 83 | 0 | 83 | 4 | 83 |
| EG001 | Placebo | Oral Placebo | 0 | 82 | 0 | 82 | 9 | 82 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | Vanda Pharmaceuticals Inc. | 202-734-3400 | clinicaltrials@vandapharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2017 | Mar 27, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
|
| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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