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NCT00945802 · ClinicalTrials.gov registry record · Phase 3

FST-201 In The Treatment of Acute Otitis Externa

A Phase 3 study, sponsored by Shire.

Terminated
Registry status
Phase 3
Development phase
5
Enrollment target

NCT00945802 is a Phase 3 study that was terminated before completion, run by Shire. The registered enrollment target is 5 participants.

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The verdict

NCT00945802, a Phase 3 study, was terminated before completion, sponsored by Shire.

TERMINATED
Registry status
Phase 3
Development phase
5 participants
Enrollment target

Study Summary

The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.

Interventions

  • DRUG FST-201 (dexamethasone 0.1%) Otic Suspension
  • DRUG ciprofloxacin 0.3%, dexamethasone 0.1%

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2009-07-31
Est. Completion 2010-07-31
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00945802

The ClinicalTrials.gov registry entry for NCT00945802 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which FST-201 (dexamethasone 0.1%) Otic Suspension is the first listed.

NCT00945802 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00945802 about?

NCT00945802 is a clinical study titled "FST-201 In The Treatment of Acute Otitis Externa". The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.

What is the current status of trial NCT00945802?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2009-07-31. Estimated completion is 2010-07-31.

What interventions are being tested in trial NCT00945802?

The interventions under investigation include: FST-201 (dexamethasone 0.1%) Otic Suspension (DRUG), ciprofloxacin 0.3%, dexamethasone 0.1% (DRUG).

Who is sponsoring clinical trial NCT00945802?

This trial is sponsored by Shire, which has 245 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.