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| ID | Type | Description | Link |
|---|---|---|---|
| 17-123 (16-817) | Other Identifier | Aurora Baycare Medical Center |
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To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.
To provide oral domperidone to patients ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation in patients whom the potential benefit may outweigh the risk of cardiovascular adverse reactions including QT prolongation, Torsades de Pointes, and death.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domperidone Oral Product | Drug | 10-30 mg of oral domperidone administered QID. |
Inclusion Criteria:
Exclusion Criteria:
History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
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| Name | Affiliation | Role |
|---|---|---|
| John Bosco, MD | Aurora BayCare Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | United States |
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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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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |