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NCT01323582 · ClinicalTrials.gov registry record · Phase 2
Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis
A Phase 2 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01323582 is a Phase 2 study that was terminated before completion, run by University of Florida. The registered enrollment target is 26 participants.
The verdict
NCT01323582, a Phase 2 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study 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.
Interventions
- DRUG Azithromycin
- DRUG Erythromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01323582
The ClinicalTrials.gov registry entry for NCT01323582 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Azithromycin is the first listed.
NCT01323582 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01323582 about?
NCT01323582 is a clinical study titled "Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis". 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 macro...
What is the current status of trial NCT01323582?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2009-02. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01323582?
The interventions under investigation include: Azithromycin (DRUG), Erythromycin (DRUG).
Who is sponsoring clinical trial NCT01323582?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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