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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01908764
First received: July 24, 2013
Last updated: July 6, 2014
Last verified: July 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: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Celeste McClean, BS, MT (ASCP) 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: July 6, 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 August 28, 2014