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Sponsored by: |
Alcon Research |
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Information provided by: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00579189 |
The purpose of this study is to determine if AL-15469A / AL-38905 is safe and effective in treating middle ear infections in patients with ear tubes.
Condition | Intervention | Phase |
---|---|---|
Acute Otitis Media With Tympanostomy Tubes |
Drug: AL-15469A / AL-38905 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT) |
Estimated Enrollment: | 660 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | April 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: AL-15469A / AL-38905
Ear drops
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2: Placebo Comparator |
Drug: AL-15469A / AL-38905
Ear drops
|
Ages Eligible for Study: | 6 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Darrell Lange | darrell.lange@alconlabs.com |
United States, Pennsylvania | |
Erie,PA | Recruiting |
Erie, Pennsylvania, United States, 16506 |
Study Director: | Sheryl Dupree | Alcon Research |
Responsible Party: | Alcon ( Sheryl Dupree ) |
Study ID Numbers: | C-05-36 |
Study First Received: | December 19, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00579189 |
Health Authority: | United States: Food and Drug Administration |
ear tubes ear drainage ear infection ear drops |
Otorhinolaryngologic Diseases Otitis Otitis Media Ear Diseases |