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PI withdrew due to increased responsibilities in clinical department.
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domperidone | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief for patients with gastrointestinal disorders who have failed standard therapy | As long as the subjects continue to take Domperidone. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Batey, M.D. | Carle Health Care Incorporated d/b/a Carle Physician Group | Principal Investigator |
| Anna Keck, PhD | Carle Foundation Hospital | Study Director |
| James Dougherty, MD | Carle Foundation Hospital | Study Director |
| Eugene Greenberg, MD | Carle Physician Group | Principal Investigator |
| Vicki Shah, PA | Carle Physician Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carle Health Care Incorporated d/b/a Carle Physician Group | Urbana | Illinois | 61801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16997628 | Background | 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. | |
| 17488253 | Background | 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. |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D005764 | Gastroesophageal Reflux |
| D004941 | Esophagitis |
| D004415 | Dyspepsia |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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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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| 10332535 | Background | Barone JA. Domperidone: a peripherally acting dopamine2-receptor antagonist. Ann Pharmacother. 1999 Apr;33(4):429-40. doi: 10.1345/aph.18003. |
| 3527396 | Background | Champion MC, Hartnett M, Yen M. Domperidone, a new dopamine antagonist. CMAJ. 1986 Sep 1;135(5):457-61. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005759 | Gastroenteritis |
| D012817 | Signs and Symptoms, Digestive |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |