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

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 40 to 41v8
  2. Results first posted: Mar 27, 2015 Primary endpoint revised · Secondary endpoint revisedv7 Show all 3 changesShow less
    • Primary endpoint revised
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  3. Lead sponsor: Children's Hospital Colorado to University of Colorado, Denverv6
  4. Re-verified, no change to tracked fieldsv5
  5. Trial status: Recruiting to Completed Primary completion date changed from estimate of Apr 2011 to May 2011 · Site details revisedv4 Show all 3 changesShow less
    • Primary completion date changed from estimate of Apr 2011 to May 2011
    • Site details revised
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Apr 2011 Completion date: May 2011 · Study arms: 0 to 2v3 Show all 3 changesShow less
    • Completion date: May 2011
    • Study arms: 0 to 2
  2. Secondary endpoints: details revised at 1 of 1 entryv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00419380
Lead Sponsor University of Colorado, Denver
Collaborators: Genentech, Inc.
Conditions Otitis Media
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov