Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)



Status:Completed
Conditions:Other Indications, Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any - 12
Updated:8/9/2018
Start Date:November 17, 2015
End Date:June 24, 2016

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An Open-Label, Single-Dose, Pharmacokinetic Study of EXE844 Sterile Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery

The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic
Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects,
immediately after bilateral tympanostomy tube surgery.


Inclusion Criteria:

- Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and
eligible for bilateral myringotomy and tympanostomy tube insertion;

- Legally Authorized Representative (LAR) must read and sign the informed consent;

- Parent or caregiver must agree to complete the required study visits and comply with
the requirements of the study;

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Menarcheal females;

- Previous otologic or otologic-related surgery within the past 30 days or ongoing
complications;

- Existing perforation of the eardrum;

- Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions
which could interfere with evaluation of the study drug;

- Any systemic disease or disorder, complicating factor or structural abnormality that
would negatively affect the conduct or outcome of the study;

- Use of prohibited medications or inadequate washout of any medication including
systemic and topical antibiotics, steroids and/or analgesics;

- Weighs less than 8 kg;

- Other protocol-specified exclusion criteria may apply.
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