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| Name | Class |
|---|---|
| Alfasigma S.p.A. | INDUSTRY |
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This is a multicenter, randomized, double-blind, incomplete block, three period fixed sequence crossover, multicenter, placebo-controlled study. The study will assess three oral doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in subjects with diabetic or idiopathic gastroparesis.
Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic gastroparesis by assessing changes in gastric emptying.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | 3-way crossover of velusetrag or placebo |
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| Sequence 2 | Experimental | 3-way crossover of velusetrag or placebo |
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| Sequence 3 | Experimental | 3-way crossover of velusetrag or placebo |
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| Sequence 4 | Experimental | 3-way crossover of velusetrag or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| velusetrag dose 1 | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying half time (GE t1/2) | From baseline to week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of lag time to gastric emptying (tlag) | From baseline to Week 5 | |
| Vital signs | Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis | From baseline to Day 49 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Sun Clinical Research | Tucson | Arizona | 85710 | United States | ||
| Axis Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33811761 | Derived | Kuo B, Barnes CN, Nguyen DD, Shaywitz D, Grimaldi M, Renzulli C, Canafax D, Parkman HP. Velusetrag accelerates gastric emptying in subjects with gastroparesis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 study. Aliment Pharmacol Ther. 2021 May;53(10):1090-1097. doi: 10.1111/apt.16344. Epub 2021 Apr 3. |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| C533727 | TD-5108 |
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| velusetrag dose 2 | Drug |
|
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| velusetrag dose 3 | Drug |
|
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| placebo | Drug |
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| ECGs | From baseline to Day 49 |
| Number of adverse events | From baseline to Day 49 |
| Los Angeles |
| California |
| 90036 |
| United States |
| Ventura Clinical Trials | Ventura | California | 93003 | United States |
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| GI Associates & Endoscopy Center | Jackson | Mississippi | 39202 | United States |
| Center for Digestive and Liver Diseases, Inc. | Mexico | Missouri | 65265 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Northwest Gastroenterology Clinic | Portland | Oregon | 97210 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |