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To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tradipitant | Experimental | Oral Capsule |
|
| Placebo | Placebo Comparator | Oral Capsule |
|
| Open Label Tradipitant | Experimental | Oral Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tradipitant | Drug | BID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD) | A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary | A patient reported daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe). Other symptoms include vomiting, postprandial fullness, early satiety, and abdominal pain | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Birmingham | Alabama | 53244 | United States | ||
| Vanda Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38237696 | Result | Carlin JL, Polymeropoulos C, Camilleri M, Lembo A, Fisher M, Kupersmith C, Madonick D, Moszczynski P, Smieszek S, Xiao C, Birznieks G, Polymeropoulos MH. The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2506-2516. doi: 10.1016/j.cgh.2024.01.005. Epub 2024 Jan 17. |
| Label | URL |
|---|---|
| Study Website | View source |
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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 | Oct 27, 2022 | Mar 19, 2024 |
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| Drug |
BID |
|
| Open Label Tradipitant | Drug | BID |
|
| Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM) | PAGI-SYM is a patient reported outcome that measures specific symptoms of patients with upper gastrointestinal disorders such as gastroparesis, GERD, and dyspepsia on a 0-5 Likert Scale (0=none, 5=very severe). | 12 weeks |
| Change from baseline in Patient Global Impression - Change (PGI-C) | A patient reported outcome measuring a patient's rating of overall improvement after treatment on a 7 point scale that includes items "1=very much worse" and "7=very much improved" | 12 weeks |
| Clinician Global Impression - Severity (CGI-S) | A clinician reported outcome that measures the clinician's view of the patient's global functioning prior to and after initiating treatment. Symptom severity is measured on a 7 point scale including "1=normal, not at all ill" and "7=among the most extremely ill patients." | 12 weeks |
| Safety and tolerability as measured by spontaneous reporting of adverse events (AEs) | Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires. | 12 weeks |
| Peoria |
| Arizona |
| 85381 |
| United States |
| Vanda Investigational Site | Little Rock | Arkansas | 72211 | United States |
| Vanda Investigational Site | Chula Vista | California | 91910 | United States |
| Vanda Investigational Site | La Jolla | California | 92093 | United States |
| Vanda Investigational Site | Los Angeles | California | 90010 | United States |
| Vanda Investigational Site | Los Angeles | California | 90026 | United States |
| Vanda Investigational Site | Maitland | Florida | 32751 | United States |
| Vanda Investigational Site | Palmetto Bay | Florida | 33157 | United States |
| Vanda Investigational Site | Tampa | Florida | 33613 | United States |
| Vanda Investigational Site | Morrow | Georgia | 30260 | United States |
| Vanda Investigational Site | Wauconda | Illinois | 60084 | United States |
| Vanda Investigational Site | West Des Moines | Iowa | 50265 | United States |
| Vanda Investigational Site | Wichita | Kansas | 67214 | United States |
| Vanda Investigational Site | Louisville | Kentucky | 40202 | United States |
| Vanda Investigational Site | Marrero | Louisiana | 70072 | United States |
| Vanda Investigational Site | Chevy Chase | Maryland | 20815 | United States |
| Vanda Investigational Site | Boston | Massachusetts | 02114 | United States |
| Vanda Investigational Site | Boston | Massachusetts | 02115 | United States |
| Vanda Investigational Site | Chesterfield | Missouri | 63005 | United States |
| Vanda Investigational Site | Las Vegas | Nevada | 89121 | United States |
| Vanda Investigational Site | Brooklyn | New York | 11201 | United States |
| Vanda Investigational Site | Charlotte | North Carolina | 28209 | United States |
| Vanda Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Vanda Investigational Site | Columbus | Ohio | 43214 | United States |
| Vanda Investigational Site | Huber Heights | Ohio | 45424 | United States |
| Vanda Investigational Site | Edmond | Oklahoma | 73034 | United States |
| Vanda Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| Vanda Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Vanda Investigational Site | Chattanooga | Tennessee | 37421 | United States |
| Vanda Investigational Site | Nashville | Tennessee | 37211 | United States |
| Vanda Investigational Site | Houston | Texas | 77043 | United States |
| Vanda Investigational Site | Houston | Texas | 77084 | United States |
| Vanda Investigational Site | Plano | Texas | 75024 | United States |
| Vanda Investigational Site | San Antonio | Texas | 78215 | United States |
| Vanda Investigational Site | Salt Lake City | Utah | 84132 | United States |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2022 | Mar 19, 2024 | SAP_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2026 | Apr 17, 2026 | 7 | ||
| Jun 9, 2026 | Jul 6, 2026 | 8 | ||
| Jul 7, 2026 |
| 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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