Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT00760461
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Age 18 and older
* Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
* Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
* Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
* Increased prolactin levels
* Breast changes
* Extrapyramidal side effects
* Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)
Exclusion Criteria:
* History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients 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. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
* Gastrointestinal hemorrhage or obstruction.
* Presence of a prolactinoma (prolactin-releasing pituitary tumor).
* Pregnant or breast feedings female.
* Known allergy to domperidone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00760461
Study Brief:
Protocol Section:
NCT00760461