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This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 10, 20, or 40 mg Naronapride vs. placebo for the treatment of patients with Gastroparesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naronapride 10 mg | Experimental |
| |
| Naronapride 20 mg | Experimental |
| |
| Naronapride 40 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naronapride | Drug | Naronapride is a 5HT-4 agonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary total score from baseline to week 12 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Falk Investigational Site | Chula Vista | California | 91910 | United States | ||
| Dr Falk Investigational Site |
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| Placebo | Drug | Placebo |
|
| Lomita |
| California |
| 90717 |
| United States |
| Dr Falk Investigational Site | Clearwater | Florida | 33756 | United States |
| Dr Falk Investigational Site | Doral | Florida | 33126 | United States |
| Dr Falk Investigational Site | Hollywood | Florida | 33021 | United States |
| Dr Falk Investigational Site | Maitland | Florida | 32751 | United States |
| Dr Falk Investigational Site | Miami | Florida | 33144 | United States |
| Dr Falk Investigational Site | Miami | Florida | 33183 | United States |
| Dr Falk Investigational Site | Viera | Florida | 32940 | United States |
| Dr Falk Investigational Site | Topeka | Kansas | 66606 | United States |
| Dr Falk Investigational Site | Crestview Hills | Kentucky | 41017 | United States |
| Dr Falk Investigational Site | Houma | Louisiana | 70363 | United States |
| Dr Falk Investigational Site | Marrero | Louisiana | 70072 | United States |
| Dr Falk Investigational Site | Flint | Michigan | 48439 | United States |
| Dr Falk Investigational Site | Flint | Michigan | 48503 | United States |
| Dr Falk Investigational Site | New York | New York | 10033 | United States |
| Dr Falk Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| Dr Falk Investigational Site | Philadelphia | Pennsylvania | 19087 | United States |
| Dr Falk Investigational Site | Cordova | Tennessee | 38018 | United States |
| Dr Falk Investigational Site | Nashville | Tennessee | 37211 | United States |
| Dr Falk Investigational Site | Harlingen | Texas | 78550 | United States |
| University of Leuven | Leuven | Belgium |
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D003920 | Diabetes Mellitus |
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C517618 | ATI 7505 |
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