Overview

Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis

Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Erythromycin is effectively used in the treatment of Gastroparesis (GP) patients. In susceptible patients however, it has been associated with sudden cardiac death due to prolongation of QT intervals and subsequent cardiac risks through its interaction some other drugs. Azithromycin (AZI) is a macrolide antibiotic but does not have the mentioned druf interactions , has fewer gastrointestinal side effects, and fewer risks of QT prolongation and cardiac arrhythmias. Consequently, AZI avoids drawbacks of dosing with erythromycin and may be preferred as a prokinetic agent in patients on other concomitant medications. We hope to demonstrate the effectiveness of Azithromycin (AZI) as compared to Erythromycin in the treatment of Gastroparesis (GP), and later, form the framework for larger randomized-controlled parallel studies to investigate use of AZI for treatment of GP. Our novel hypothesis is to determine whether AZI can be used to treat GP.
Phase:
Phase 2
Details
Lead Sponsor:
University of Florida
Collaborator:
Metabolic Solutions Inc.
Treatments:
Azithromycin
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate