Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT02037893
Eligibility Criteria:
Inclusion Criteria:
* Clinical Diagnosis of Acute Otitis Media
* Moderate to severe pain
* Normally active and in good health as determined by the PI
* Parent or legal guardian consent
* Caregiver available to complete diaries during study
Exclusion Criteria:
* History of or current Perforated tympanic membrane
* Tympanostomy tubes
* Acute or chronic otitis externa
* seborrheic dermatitis
* Received any otic topical or systemic antibiotic within 14 days of enrollment
* Receiving medication on a chronic basis for pain
* Known hypersensitivity to investigational product.
* clinical significant mental illness as determined by the PI
* Exposed to another investigational agent within 30 days before study entry. Any condition the PI believed will interfere with the ability to comply with all study procedures
* History of glucose 6-phosphate dehydrogenase deficiency
* History or currently anemic
* Congenital methemoglobinemia
* Recent history of acute gastroenteritis within 14 days of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
12 Years
Study:
NCT02037893
Study Brief:
Protocol Section:
NCT02037893