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NCT00419380 · ClinicalTrials.gov registry record · Phase 4

Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)

A Phase 4 study, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 4
Development phase
41
Enrollment target

NCT00419380: Completed Phase 4 study, sponsored by University of Colorado, Denver.

NCT00419380 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 41 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00419380, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 4
Development phase
41 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the new drug for any problems related to the medication. Patients are being asked to be in this study because they had tubes placed for the treatment of chronic ear infection and the tube(s) are now clogged. Clogged tubes are a common problem found in children with tubes. This problem occasionally is improved with ear drops like Floxin®. However, it is frequently not improved even after this standard ear drop treatment.

Interventions

  • DRUG dornase alfa (Pulmozyme®)

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2007-01
Est. Completion 2011-05
Phase Phase 4
University of Colorado, Denver

1,283 total trials

What the finished NCT00419380 record still lists

NCT00419380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which dornase alfa (Pulmozyme®) is the first listed.

NCT00419380 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00419380 about?

NCT00419380 is a clinical study titled "Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)". The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the new drug for any problems related to the medication. Patients are being asked to be in this study because they had tu...

What is the current status of trial NCT00419380?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2007-01. Estimated completion is 2011-05.

What interventions are being tested in trial NCT00419380?

The interventions under investigation include: dornase alfa (Pulmozyme®) (DRUG).

Who is sponsoring clinical trial NCT00419380?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00419380's enrollment target sits among peer trials

41 1390th of 2000 higher than 604 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT00419380, the US trial registry maintained by the National Library of Medicine. NCT00419380 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.