Domperidone for Relief of Gastrointestinal Disorders

Carle Physician Group

Status

Terminated

Conditions

Vomiting

Esophagitis

Nausea

Gastroparesis

Dyspepsia

Chronic Idiopathic Constipation

GERD

Treatments

Drug: Domperidone

Study type

Interventional

Identifiers

NCT00761254

08-153

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.