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Enrolled subjects were unable to receive drug from dispensing pharmacy.
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The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Domperidone | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domperidone | Drug | 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastroparesis Cardinal Symptom Index | upon study completion |
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Inclusion Criteria:
Male or female
Age 18 and older
Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anish A Sheth, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Digestive Diseases 40 Temple St, Suite 1A | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Domperidone | Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Domperidone | Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age was not collected and summarized. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gastroparesis Cardinal Symptom Index | Data cannot be summarized or analyzed due to the lack of data being collected on the primary outcome due to the trial being terminated. | Posted | upon study completion |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Domperidone | Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anish A Sheth M.D | Yale University | 203-785-4576 | anish.sheth@yale.edu |
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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 |
|---|---|
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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Age was not collected and summarized.
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 0 |
| 44 |
| 0 |
| 44 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |