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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: Clinical Trial Phase 3 study, sponsored by Shire.
NCT00945802 is a Phase 3 study that was terminated before completion, run by Shire. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2009-07-31 |
| Est. Completion | 2010-07-31 |
| Phase | Phase 3 |
Why NCT00945802 stopped before completion
NCT00945802 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which FST-201 (dexamethasone 0.1%) Otic Suspension is the first listed.
NCT00945802 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00945802's enrollment target sits among peer trials
5 1997th of 2000 higher than 3 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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