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The purpose of this program is to allow the use of domperidone in children from 12 to 21 years of age with symptoms related to motility disorders and Gastroesophageal reflux disease (GERD) who have failed all the standard treatments for their condition.
The following will need to be completed before the investigational treatment can begin:
If your tests results are acceptable, the following will happen to you:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall Study | Other | Receive domperidone 4 times a day, weight-dependent dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domperidone | Drug | Domperidone taken 4 times a day, dose based on body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease severity | refractory gastroparesis or GERD(Gastroesophageal Reflux Disease) | Up to 1 year |
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Inclusion Criteria:
Male or female
Age 12 - 21
Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Corey Schurman, MA, CCRC | Contact | 816-302-3076 | crschurman@cmh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jose Cocjin, MD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospitals and Clinics | Recruiting | Kansas City | Missouri | 64108 | United States |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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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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| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |