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 |
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.
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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