Clinical trial NCT01908764: Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery
Official title: An Open-Label, Single Dose, Pharmacokinetic Study of AL-60371 Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Otitis Media
Keywords: ear tubes
tympanostomy tubes
Otitis Media at the time of Tympanostomy Tube surgery
OMTT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.


Eligibility criteria: Inclusion Criteria:

* Requires bilateral myringotomy and tympanostomy tube insertion;
* Provides informed consent (parent/legal guardian);
* Signs assent form where applicable (subject);
* Accompanied by parent/legal guardian at each visit;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Menarcheal females;
* Current or recent history of any disease which, in the opinion of the Principal Investigator, may place the subject at risk or interfere with study;
* Use of excluded medications within one week prior to surgery and for the duration of the study;
* Requires another surgical procedure in addition to the myringotomy;
* Clinically relevant otic condition which, in the opinion of the Principal Investigator, would preclude the safe administration of the study medication;
* Participation in any other investigational study within 30 days before entry into this study or along with this study;
* Known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Maximum observed analyte plasma concentration (Cmax)
timeFrame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
measure: Time to reach Cmax (Tmax)
timeFrame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
measure: Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last)
timeFrame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
measure: Area under the concentration-time curve from 0 to infinity (AUC0-∞)
timeFrame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
measure: Time to last measurable concentration (Tlast)
timeFrame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
measure: The terminal elimination half (T½)
timeFrame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Celeste McClean, BS, MT (ASCP)
role: STUDY_DIRECTOR
References: