Status:
COMPLETED
Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Otitis Media
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
The success in treating blocked tubes may relate to the ability to dissolve the material clogging the tube as well as dealing with the thick fluid in the middle-ear. The reasoning behind this study is...
Eligibility Criteria
Inclusion
- subjects from age 1 to 18 years who have undergone tube placement in the previous 9 months.
- subjects with middle-ear fluid on entry into the study will be required to have had a prior normal hearing test.
Exclusion
- subjects with symptoms of an acute otitis media (otalgia or otorrhea), sensorineural hearing loss,cranio-facial syndromes, cystic fibrosis, prior ear surgery except tube placement, sensitivity to fluoroquinolones and presence of granulation tissue in the lumen of the tympanostomy tubes will be excluded.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00419380
Start Date
January 1 2007
End Date
May 1 2011
Last Update
March 27 2015
Active Locations (1)
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1
The Children's Hospital
Denver, Colorado, United States, 80218