Clinical trial NCT02539654: Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
Official title: An Open-Label, Single-Dose, Pharmacokinetic Study of EXE844 Sterile Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Otitis Media With Effusion in Children
Otitis Media Recurrent
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-09-03
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Analyte Plasma Concentration (Cmax)
timeFrame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
measure: Time to Reach Maximum Concentration (Tmax)
timeFrame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
measure: Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last)
timeFrame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
measure: Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf)
timeFrame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
measure: Time to Last Measurable Concentration (Tlast)
timeFrame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
measure: Terminal Elimination Half-life (T1/2)
timeFrame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research
name: Clinical Manager, GCRA, Pharma
role: STUDY_DIRECTOR
References: