- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00761254
Domperidone for Relief of Gastrointestinal Disorders
Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Urbana, Illinois, United States, 61801
- Carle Health Care Incorporated d/b/a Carle Physician Group
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 de 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relief for patients with gastrointestinal disorders who have failed standard therapy
Time Frame: As long as the subjects continue to take Domperidone.
|
As long as the subjects continue to take Domperidone.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Batey, M.D., Carle Health Care Incorporated d/b/a Carle Physician Group
- Study Director: Anna Keck, PhD, Carle Foundation Hospital
- Study Director: James Dougherty, MD, Carle Foundation Hospital
- Principal Investigator: Eugene Greenberg, MD, Carle Physician Group
- Principal Investigator: Vicki Shah, PA, Carle Physician Group
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Stomach Diseases
- Gastroenteritis
- Esophageal Diseases
- Paralysis
- Dyspepsia
- Vomiting
- Gastrointestinal Diseases
- Digestive System Diseases
- Constipation
- Gastroparesis
- Esophagitis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dopamine Agents
- Dopamine Antagonists
- Domperidone
Other Study ID Numbers
- 08-153
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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