Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
42 participants
INTERVENTIONAL
2008-08-31
2012-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Domperidone
Initially, 10mg of oral Domperidone will be administered 2-4 times a day as needed. This dosage may be increased or decreased depending on how the subject responds to the drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Carle Physician Group
INDIV
Responsible Party
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Principal Investigators
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Andrew Batey, M.D.
Role: PRINCIPAL_INVESTIGATOR
Carle Health Care Incorporated d/b/a Carle Physician Group
Anna Keck, PhD
Role: STUDY_DIRECTOR
Carle Foundation Hospital
James Dougherty, MD
Role: STUDY_DIRECTOR
Carle Foundation Hospital
Eugene Greenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Carle Physician Group
Vicki Shah, PA
Role: PRINCIPAL_INVESTIGATOR
Carle Physician Group
Locations
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Carle Health Care Incorporated d/b/a Carle Physician Group
Urbana, Illinois, United States
Countries
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References
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Ahmad N, Keith-Ferris J, Gooden E, Abell T. Making a case for domperidone in the treatment of gastrointestinal motility disorders. Curr Opin Pharmacol. 2006 Dec;6(6):571-6. doi: 10.1016/j.coph.2006.07.004. Epub 2006 Sep 25.
Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007 Sep;102(9):2036-45. doi: 10.1111/j.1572-0241.2007.01255.x. Epub 2007 May 3.
Barone JA. Domperidone: a peripherally acting dopamine2-receptor antagonist. Ann Pharmacother. 1999 Apr;33(4):429-40. doi: 10.1345/aph.18003.
Champion MC, Hartnett M, Yen M. Domperidone, a new dopamine antagonist. CMAJ. 1986 Sep 1;135(5):457-61.
Other Identifiers
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08-153
Identifier Type: -
Identifier Source: org_study_id