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

StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Enrollment target: 40 to 41v8
  2. Results first posted: Mar 27, 2015
    • Primary endpoint revised
    • Secondary endpoint revised
    v7
  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 revised
    v4
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  1. Primary completion date: Apr 2011
    • Study completion date: May 2011
    • Study arms: 0 to 2
    v3
  2. Secondary endpoints: details revised at 1 of 1 entryv2
  1. Study First Submitted
  • 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
(from sponsor)		 Otitis Media
Related terms Otitis Media
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov