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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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01449188 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Two doses of ondansetron willl be used, 8mg and 32mg. The change in QTcF will be time-matched, baseline adjusted and compared to placebo.
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 |
What the finished NCT01449188 record still lists
NCT01449188 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which saline is the first listed.
NCT01449188 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01449188's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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