Domperidone for Relief of Gastrointestinal Disorders - NCT00761254-61801 (Clinical Trial 243502)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy243502.aspx
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| City: |
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Urbana |
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State:
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IL |
| Zip Code: |
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61801 |
| Conditions: |
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Gastroparesis - GERD - Esophagitis |
| Purpose: |
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The purpose of this study is to make Domperidone available to patients with gastrointestinal
disorders who have failed standard therapy and who might benefit from it.
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| Study summary: |
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Domperidone is the only medication that is a true prokinetic with a low percentage of side
effects that is useful in the treatment of certain GI conditions, including gastroparesis
and other motility disorders.
According to recent regulations, writing prescriptions for subject to obtain domperidone
outside the United States has been determined to be illegal and the FDA has issued warnings
against pharmacies compounding domperidone. The legal way of administering domperidone is by
obtaining an Investigational New Drug Application.
This study is an effort to both follow federal regulations and provide the medication to
subjects who would benefit from it where standard therapy has failed. |
| Criteria: |
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Inclusion Criteria:
- 18 years or older
- 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 is refractory to standard therapy
- subjects must have a comprehensive evaluation to eliminate other causes of their
symptoms.
Exclusion Criteria:
- history of, or current, arrhythmias including ventricular tachycardia, ventricular
fibrillation, and Torsade des Pointes. Subjects 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.
- gastrointestinal hemorrhage or obstruction.
- presence of a prolactinoma (prolactin-releasing pituitary tumor.)
- pregnant or breast feeding female.
- known allergy to Domperidone. |
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| Study is available at: |
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Carle Clinic Association
Urbana, IL 61801
United States
Primary Contact:
Micki Suits, RN
Email: micki.suits@carle.com
Phone: 217-326-0058
Secondary Contact:
Micki J Suits, RN
Email: micki.suits@carle.com
Phone: 217-326-0058 |
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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 16, 2009 |
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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