Status:
UNKNOWN
Domperidone for Refractory Gastrointestinal Disorders
Lead Sponsor:
Arnold, George, M.D.
Conditions:
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.
Detailed Description
Domperidone is a dopamine-2 receptor antagonist. It acts as a prokinetic agent through its effects on the chemoreceptor trigger zone and the motor function of the stomach and small intestines. It does...
Eligibility Criteria
Inclusion
- Male or female
- Age 18 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 are refractory to standard therapy.
- Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
- Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:
- increased prolactin levels
- extrapyramidal side effects
- breast changes
- cardiac arrhythmias including QT prolongation
- there is a potential for increased risk of adverse events with the drugs listed in the addendum
Exclusion
- History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
- 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 QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo- obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
- Pregnant or breast feeding female.
- Known allergy to domperidone or any components of the domperidone formulation.
- Significantly significant electrolyte disorders.
- Gastrointestinal hemorrhage or obstruction.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00777439
Start Date
October 1 2008
End Date
January 1 2018
Last Update
August 18 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Division of Gastroenterology, Hepatology and Nutrition, UPMC Presbyterian Digesive Disorders Center, 3rd Floor, 200 Lothrop Street
Pittsburgh, Pennsylvania, United States, 15213