Domperidone in Refractory Gastroparesis - NCT00760461-06510 (Clinical Trial 243377)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy243377.aspx
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| City: |
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New Haven |
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State:
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CT |
| Zip Code: |
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06510 |
| Conditions: |
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Gastroparesis |
| Purpose: |
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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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| Study summary: |
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| Criteria: |
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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:
- Increased prolactin levels
- Breast changes
- Extrapyramidal side effects
- Cardiac arrhythmias including QT prolongation (increased risk with the drugs
listed in the appendix)
Exclusion Criteria:
- History of, or current, arrhythmias including ventricular tachycardia, ventricular
fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are
not necessarily excluded.
- Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged
QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females)
- Clinically significant electrolyte disorders. These include significant hypokalemia,
hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with
treatment of these electrolyte abnormalities.
- Gastrointestinal hemorrhage or obstruction.
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Pregnant or breast feedings female.
- Known allergy to domperidone |
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| Study is available at: |
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Yale Digestive Diseases 40 Temple St, Suite 1A
New Haven, CT 06510
United States
Primary Contact:
Christal M Esposito
Email: christal.esposito@yale.edu
Phone: 203-785-4576
Secondary Contact:
Christal M Esposito
Email: christal.esposito@yale.edu
Phone: 203-785-4576 |
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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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March 16, 2010 |
Modifications to
this listing: |
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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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