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| ID | Type | Description | Link |
|---|---|---|---|
| EPIONE2 | Other Identifier | Vanda Pharmaceuticals Inc. |
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Business Decision
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This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tradipitant | Experimental | Oral Capsule |
|
| Placebo | Placebo Comparator | Oral Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tradipitant | Drug | BID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2 | The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable". | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Hoover | Alabama | 35244 | United States | ||
| Vanda Investigational Site |
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| Label | URL |
|---|---|
| Study Webpage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tradipitant | Oral Capsule Tradipitant: BID |
| FG001 | Placebo | Oral Capsule Placebo: BID |
| 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 | Jun 2, 2022 | Mar 19, 2024 |
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| Drug |
BID |
|
| Tempe |
| Arizona |
| 85281 |
| United States |
| Vanda Investigational Site | Encino | California | 91436 | United States |
| Vanda Investigational Site | Fountain Valley | California | 92708 | United States |
| Vanda Investigational Site | Laguna Hills | California | 92653 | United States |
| Vanda Investigational Site | Lomita | California | 90717 | United States |
| Vanda Investigational Site | Los Angeles | California | 90025 | United States |
| Vanda Investigational Site | Los Angeles | California | 90036 | United States |
| Vanda Investigational Site | Los Angeles | California | 90057 | United States |
| Vanda Investigational Site | Denver | Colorado | 80220 | United States |
| Vanda Investigational Site | Clearwater | Florida | 33756 | United States |
| Vanda Investigational Site | Miami | Florida | 33126 | United States |
| Vanda Investigational Site | Tampa | Florida | 33613 | United States |
| Vanda Investigational Site | Savannah | Georgia | 31406 | United States |
| Vanda Investigational Site | Boise | Idaho | 83704 | United States |
| Vanda Investigational Site | Chicago | Illinois | 60611 | United States |
| Vanda Investigational Site | Normal | Illinois | 61761 | United States |
| Vanda Investigational Site | Skokie | Illinois | 60077 | United States |
| Vanda Investigational Site | Plainfield | Indiana | 46168 | United States |
| Vanda Investigational Site | Crowley | Louisiana | 70526 | United States |
| Vanda Investigational Site | Timonium | Maryland | 21093 | United States |
| Vanda Investigational Site | Fort Gratiot | Michigan | 48059 | United States |
| Vanda Investigational Site | Saint Joseph | Missouri | 64506 | United States |
| Vanda Investigational Site | St Louis | Missouri | 63141 | United States |
| Vanda Investigational Site | Omaha | Nebraska | 68144 | United States |
| Vanda Investigational Site | Las Vegas | Nevada | 89119 | United States |
| Vanda Investigational Site | Berlin | New Jersey | 08009 | United States |
| Vanda Investigational Site | Hoboken | New Jersey | 07030 | United States |
| Vanda Investigational Site | Verona | New Jersey | 07044 | United States |
| Vanda Investigational Site | Kew Gardens | New York | 11415 | 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 | The Bronx | New York | 10458 | United States |
| Vanda Investigational Site | Charlotte | North Carolina | 28277 | United States |
| Vanda Investigational Site | Cincinnati | Ohio | 45212 | United States |
| Vanda Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Vanda Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Vanda Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| Vanda Investigational Site | Johnston | Rhode Island | 02919 | United States |
| Vanda Investigational Site | Spartanburg | South Carolina | 29301 | United States |
| Vanda Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| Vanda Investigational Site | Dallas | Texas | 75230 | United States |
| Vanda Investigational Site | Houston | Texas | 77004 | United States |
| Vanda Investigational Site | Houston | Texas | 77065 | United States |
| Vanda Investigational Site | Mesquite | Texas | 75149 | United States |
| Vanda Investigational Site | South Jordan | Utah | 84095 | United States |
| Vanda Investigational Site | South Burlington | Vermont | 05403 | United States |
| Vanda Investigational Site | Alexandria | Virginia | 22311 | United States |
| Vanda Investigational Site | Newport News | Virginia | 23606 | United States |
| Vanda Investigational Site | Norfolk | Virginia | 23502 | United States |
| Vanda Investigational Site | Spokane | Washington | 99202 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tradipitant | Oral Capsule Tradipitant: BID |
| BG001 | Placebo | Oral Capsule Placebo: BID |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2 | The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable". | All participants randomized (1:1) to placebo or tradipitant. | Posted | Count of Participants | Participants | 2 weeks |
|
|
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All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.
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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 Capsule Tradipitant: BID | 0 | 43 | 1 | 43 | 13 | 43 |
| EG001 | Placebo | Oral Capsule Placebo: BID | 0 | 44 | 1 | 44 | 10 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Obstructive Pancreatitis | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Chlamydial Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Herpes Virus Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Angular Cheilitis | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Feces Discolored | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Obstructive Pancreatitis | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Arthropod Sting | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Heart Rate Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Liver Function Test Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Periorbital Oedema | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
This study was discontinued early and therefore the study was not powered for appropriate examination of primary and secondary endpoints.
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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 | Jun 2, 2022 | Mar 19, 2024 | SAP_001.pdf |
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| 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 |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|