Gastroparesis
Conditions
Brief summary
The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.
Interventions
DRUGDomperidone
10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastroparesis Cardinal Symptom Index | upon study completion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Domperidone Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Domperidone |
|---|---|
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Gastroparesis Cardinal Symptom Index
Time frame: upon study completion
Population: Data cannot be summarized or analyzed due to the lack of data being collected on the primary outcome due to the trial being terminated.