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NCT01069900 · ClinicalTrials.gov registry record · Phase 3
Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 458
- Enrollment target
NCT01069900 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 458 participants.
The verdict
NCT01069900, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 458 participants
- Enrollment target
Study Summary
The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin in a pediatric population 3 months to \<18 years old. Approximately 450 pediatric subjects with a complicated intra-abdominal infection will be enrolled in the study and treated with either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.
Interventions
- DRUG Moxifloxacin (Avelox, BAY12-8039)
- DRUG Ertapenem
- DRUG Moxifloxacin placebo
- DRUG Amoxicillin/Clavulanate
- DRUG Ertapenem placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2010-07-21 |
| Est. Completion | 2015-01-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01069900
The ClinicalTrials.gov registry entry for NCT01069900 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 458 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Moxifloxacin (Avelox, BAY12-8039) is the first listed.
NCT01069900 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01069900 about?
NCT01069900 is a clinical study titled "Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection". The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin in a pediatric population 3 months to \<18 years old. Approximately 450 pediatric subjects with a complicated intra-abdominal infection will be enrolled in the study and treated with either moxifloxacin int...
What is the current status of trial NCT01069900?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 458 participants. The study started on 2010-07-21. Estimated completion is 2015-01-21.
What interventions are being tested in trial NCT01069900?
The interventions under investigation include: Moxifloxacin (Avelox, BAY12-8039) (DRUG), Ertapenem (DRUG), Moxifloxacin placebo (DRUG), Amoxicillin/Clavulanate (DRUG), Ertapenem placebo (DRUG).
Who is sponsoring clinical trial NCT01069900?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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