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NCT01449188 · ClinicalTrials.gov registry record · Phase 1
To Investigate the Effect of Intravenous Ondansetron on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01449188 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 60 participants.
The verdict
NCT01449188, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Ondansetron, also known as Zofran, is a marketed compound used for the prevention of nausea and vomiting. This study, called a thorough QT study, will characterize the effects of a single intravenous (IV) dose of ondansetron on cardiac repolarization as compared to placebo. Moxifloxacin, a commercially available antibiotic known to cause a mild QT prolongation, will be used as a positive control and will be given orally. The cardiac repolarization will be measured by taking consecutive ECGs on a recording device known as a Holter monitor and measuring the QT interval at specified times. In addition, blood samples will also be taken at specified times and will be used to measure the amount of study medication in the body.
Interventions
- OTHER saline
- DRUG ondansetron
- DRUG moxifloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-08-16 |
| Est. Completion | 2011-12-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01449188
The ClinicalTrials.gov registry entry for NCT01449188 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which saline is the first listed.
NCT01449188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01449188 about?
NCT01449188 is a clinical study titled "To Investigate the Effect of Intravenous Ondansetron on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects". Ondansetron, also known as Zofran, is a marketed compound used for the prevention of nausea and vomiting. This study, called a thorough QT study, will characterize the effects of a single intravenous (IV) dose of ondansetron on cardiac repolarization as compared to placebo. Moxifloxacin, a commercia...
What is the current status of trial NCT01449188?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-08-16. Estimated completion is 2011-12-19.
What interventions are being tested in trial NCT01449188?
The interventions under investigation include: saline (OTHER), ondansetron (DRUG), moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT01449188?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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