Domperidone for Relief of Gastrointestinal Disorders

• Status: Terminated
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carle Physician Group
• Treatments: Domperidone

Criteria

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.