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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.

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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

FieldValue
Enrollment Target 458 participants
Start Date 2010-07-21
Est. Completion 2015-01-21
Phase Phase 3

Sponsor

Bayer

591 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.