Domperidone for Gastroparesis in Solid Organ Transplantation - NCT00552422-10032 (Clinical Trial 189387)
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10032 |
| Conditions: |
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Gastroparesis - Gastroesophageal Reflux |
| Purpose: |
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The purpose of this study is to examine the clinical response to domperidone in solid organ
transplant recipients with gastroparesis.
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| Study summary: |
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After heart or lung transplantation, the stomach tends to empty much slower than normal.
This slow emptying is called "gastroparesis." Gastroparesis is uncomfortable and often leads
to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea
and vomiting can also lead to malnutrition and an inability to take oral medications,
contributing to complications of transplantation. Treatments for gastroparesis include both
medical and surgical therapies that work for some but not all patients.
Domperidone is a peripheral D2 antagonist that improves the emptying of the stomach in
patients with gastroparesis. Domperidone is not FDA approved at this time. Some patients
have developed lifethreatening abnormal heart rhythms after receiving domperidone
intravenously. This problem has not been seen with domperidone given by mouth.
We propose to administer domperidone by mouth at standard doses to solid organ transplant
patients who have gastroparesis that is not responsive to standard medical therapies or who
experience adverse drug side effects. This study will not be blinded (open-label) and has a
single treatment arm (no control or placebo group). |
| Criteria: |
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Inclusion Criteria:
- gastroparesis or gastroesophageal reflux that is refractory to standard therapy.
- signed informed consent
Exclusion Criteria:
- serious cardiac arrhythmias
- clinically significant bradycardia, sinus node dysfunction, or heart block.
- prolonged QTc
- clinically significant electrolyte disorders.
- gastrointestinal hemorrhage or obstruction.
- prolactinoma
- pregnant or breast feeding female
- known allergy to domperidone. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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