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NCT01170221 · ClinicalTrials.gov registry record · Phase 3

TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.

A Phase 3 study, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Completed
Registry status
Phase 3
Development phase
667
Enrollment target

NCT01170221 is a Phase 3 study that has completed, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 667 participants.

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The verdict

NCT01170221, a Phase 3 study, has completed, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

COMPLETED
Registry status
Phase 3
Development phase
667 participants
Enrollment target

Study Summary

This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment

Interventions

  • DRUG Linezolid
  • DRUG TR-701 FA

Trial Details

FieldValue
Enrollment Target 667 participants
Start Date 2010-08-15
Est. Completion 2011-09-30
Phase Phase 3

What the Registry Record Tells You About NCT01170221

The ClinicalTrials.gov registry entry for NCT01170221 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 667 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 18 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Linezolid is the first listed.

NCT01170221 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01170221 about?

NCT01170221 is a clinical study titled "TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.". This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Approximately 75 to 100 sites globally will participate in this study. P...

What is the current status of trial NCT01170221?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 667 participants. The study started on 2010-08-15. Estimated completion is 2011-09-30.

What interventions are being tested in trial NCT01170221?

The interventions under investigation include: Linezolid (DRUG), TR-701 FA (DRUG).

Who is sponsoring clinical trial NCT01170221?

This trial is sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 18 total clinical trials registered on ClinicalTrials.gov.

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

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.