Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery

This study is not yet open for participant recruitment.
Verified March 2014 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01908764
First received: July 24, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Otitis Media
Drug: AL-60371 otic suspension
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-Label, Single Dose, Pharmacokinetic Study of AL-60371 Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Maximum observed analyte plasma concentration (Cmax) [ Time Frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose ] [ Designated as safety issue: No ]
    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

  • Time to reach Cmax (Tmax) [ Time Frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose ] [ Designated as safety issue: No ]
    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

  • Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last) [ Time Frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose ] [ Designated as safety issue: No ]
    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

  • Area under the concentration-time curve from 0 to infinity (AUC0-∞) [ Time Frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose ] [ Designated as safety issue: No ]
    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

  • Time to last measurable concentration (Tlast) [ Time Frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose ] [ Designated as safety issue: No ]
    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

  • The terminal elimination half (T½) [ Time Frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose ] [ Designated as safety issue: No ]
    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).


Estimated Enrollment: 30
Study Start Date: April 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-60371/Posology 1
AL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes
Drug: AL-60371 otic suspension
Experimental: AL-60371/Posology 2
AL-60371 otic suspension, single dose of 4 drops following surgical insertion of tympanostomy tubes
Drug: AL-60371 otic suspension

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908764

Contacts
Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations Not yet recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Mehdi Hosseini, MD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01908764     History of Changes
Other Study ID Numbers: C-13-023
Study First Received: July 24, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
ear tubes
tympanostomy tubes
Otitis Media at the time of Tympanostomy Tube surgery
OMTT

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014