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NCT01049022 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients
A Phase 1 study of Infections, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 11
- Study locations
NCT01049022: Completed Phase 1 study of Infections, sponsored by Bayer.
NCT01049022 is a Phase 1 study of Infections that has completed, run by Bayer. The registered enrollment target is 31 participants, below the 3,406-participant average among 26 other Infections trials with a reported enrollment target (99% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01049022, a Phase 1 study of Infections, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. The pharmacokinetics of certain drugs may be altered in children due to developmental differences in various organ functions responsible for drug elimination, as well as in general distribution characteristics. The safety of moxifloxacin in children with infections will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children
Primary Outcome
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Conditions Studied
Interventions
- DRUG Moxifloxacin (Avelox, BAY12-8039)
Study Locations (11)
Ohio
- - Cincinnati
- - Cleveland
- - Toledo
California
- - Orange
- - San Diego
Arkansas
- - Little Rock
Kentucky
- - Louisville
Louisiana
- - New Orleans
Massachusetts
- - Boston
Missouri
- - Kansas City
Utah
- - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01049022 record still lists
NCT01049022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 3,406-participant average among 26 other Infections trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Infections appearing as the primary indexed condition, and to 1 intervention - of which Moxifloxacin (Avelox, BAY12-8039) is the first listed.
NCT01049022 lists 11 locations in 8 states (Ohio, California, Arkansas).
Frequently Asked Questions
What is clinical trial NCT01049022 about?
NCT01049022 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients". The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. The pharmacokinetics of certain drugs ma...
What is the current status of trial NCT01049022?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2010-05. Estimated completion is 2013-08.
What conditions does trial NCT01049022 study?
This clinical trial studies the following conditions: Infections.
What interventions are being tested in trial NCT01049022?
The interventions under investigation include: Moxifloxacin (Avelox, BAY12-8039) (DRUG).
Who is sponsoring clinical trial NCT01049022?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01049022 being conducted?
This trial has 11 study locations across Arkansas, California, Kentucky, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01049022's enrollment target sits among peer trials
31 21st of 26 higher than 6 of 26 other Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infections 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.
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