Chronic Idiopathic Constipation, Dyspepsia, Esophagitis, Gastroparesis, GERD, Nausea, Vomiting
Conditions
Keywords
Domperidone, Gastroparesis
Brief summary
The purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.
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.
Interventions
DRUGDomperidone
Initially, 10mg of oral Domperidone will be administered 2-4 times a day as needed. This dosage may be increased or decreased depending on how the subject responds to the drug.
Sponsors
Carle Physician Group
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief for patients with gastrointestinal disorders who have failed standard therapy | As long as the subjects continue to take Domperidone. |
Countries
United States
Outcome results
None listed