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:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT01908803
Eligibility Criteria:
Inclusion Criteria:
* Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
* Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
* Presence of patent tympanostomy tubes;
* Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
* Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
* Menarcheal females;
* Previous otologic surgery, except tympanic membrane, within one year of study entry;
* History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
* Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;
* Diabetic (controlled or uncontrolled);
* Use of prohibited medications;
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Years
Study:
NCT01908803
Study Brief:
Protocol Section:
NCT01908803