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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: Clinical Trial Phase 2 study, sponsored by University of Florida.
NCT01323582 is a Phase 2 study that was terminated before completion, run by University of Florida. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to empty 50% (t 1/2) of the accumulated contents is recorded. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.
Interventions
- DRUG Azithromycin
- DRUG Erythromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
Why NCT01323582 stopped before completion
NCT01323582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Azithromycin is the first listed.
NCT01323582 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01323582's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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