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Sponsored by: |
Alcon Research |
---|---|
Information provided by: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00750633 |
The purpose of this study is to determine if AL-15469A/AL-38905 is safe and effective for the treatment of acute otitits externa.
Condition | Intervention | Phase |
---|---|---|
Acute Otitis Externa |
Drug: AL-15469A/AL-38905 Drug: AL-15469A Drug: AL-38905 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment |
Estimated Enrollment: | 1500 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
AL-15469A/AL-38905: Experimental
topical antibiotic/antiinflammatory combination ear drop
|
Drug: AL-15469A/AL-38905
topical ear drop dosed 4 drops twice daily for 7 days
|
AL-15469A: Active Comparator
topical antibiotic ear drop
|
Drug: AL-15469A
topical ear drop dosed 4 drops twice daily for 7 days
|
AL-38905: Active Comparator
topical antiinflammatory ear drop
|
Drug: AL-38905
topical ear drop dosed 4 drops twice daily for 7 days
|
Ages Eligible for Study: | 6 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alcon Call Center | 1-888-451-3937 |
United States, Texas | |
Alcon Call Center for Trial Locations | Recruiting |
Fort Worth, Texas, United States, 76134 | |
Contact: Sheryl J Dupre, MS 817-551-8600 ext 8600 sheryl.dupre@alconlabs.com |
Responsible Party: | Alcon Research, Ltd. ( Sheryl J. Dupre, M.S./Associate Director ) |
Study ID Numbers: | C-07-13 |
Study First Received: | September 8, 2008 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00750633 |
Health Authority: | United States: Food and Drug Administration |
swimmer's ear, ear drops, ear infection, ear pain, ear inflammation |
Otorhinolaryngologic Diseases Otitis Pain |
Otitis Externa Ear Diseases Inflammation |