Status:
TERMINATED
Domperidone for Relief of Gastrointestinal Disorders
Lead Sponsor:
Carle Physician Group
Conditions:
Gastroparesis
GERD
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00761254
Start Date
August 1 2008
End Date
September 1 2012
Last Update
September 13 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Carle Health Care Incorporated d/b/a Carle Physician Group
Urbana, Illinois, United States, 61801