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Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant
This is a single-patient extended access treatment protocol to be conducted in the United States. Investigator-Physician has determined patient satisfies expanded access inclusion criteria and has requested expanded access to tradipitant.
Patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour intervals for long term treatment. Patient can fill out daily web-based symptom diaries on a voluntary basis and report any adverse events to Investigator-Physician.
Primary Objective:
-To treat a single patient with gastroparesis who has requested expanded access with tradipitant
Secondary Objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tradipitant | Drug | NK-1 Receptor antagonist |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals | Contact | 2027343400 | clinicaltrials@vandapharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Available | Maitland | Florida | 32751 | United States |
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| Vanda Investigational Site | Available | Tampa | Florida | 33613 | United States |
|
| Vanda Investigational Site | Available | Wauconda | Illinois | 60084 | United States |
|
| Vanda Investigational Site | Available | Wichita | Kansas | 67214 | United States |
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| Vanda Investigational Site | Available | Louisville | Kentucky | 40202 | United States |
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| Vanda Investigational Site | Available | Chevy Chase | Maryland | 20815 | United States |
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| Vanda Investigational Site | Available | Boston | Massachusetts | 02215 | United States |
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| Vanda Investigational Site | Available | Chesterfield | Missouri | 63005 | United States |
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| Vanda Investigational Site | Available | Charlotte | North Carolina | 28209 | United States |
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| Vanda Investigational Site | Available | Tulsa | Oklahoma | 74104 | United States |
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| Vanda Investigational Site | Available | Philadelphia | Pennsylvania | 19104 | United States |
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| Vanda Investigational Site | Available | Nashville | Tennessee | 37211 | United States |
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| Vanda Investigational Site | Available | Houston | Texas | 77084 | United States |
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| Vanda Investigational Site | Available | Plano | Texas | 75024 | United States |
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| Vanda Investigational Site | Available | Spokane | Washington | 99202 | United States |
|
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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