Domperidone for Refractory Gastrointestinal Disorders (NCT00777439) | Clinical Trial Compass
UnknownNot Applicable
Domperidone for Refractory Gastrointestinal Disorders
United States75 participantsStarted 2008-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 …
What they're measuring
1
Improvement of symptoms for patients with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.
Timeframe: Domperidone will be prescrided as long as patients benefit from taking it.