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

Primary Purpose

Otitis Media

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AL-60371 otic suspension
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Otitis Media focused on measuring ear tubes, tympanostomy tubes, Otitis Media at the time of Tympanostomy Tube surgery, OMTT

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    AL-60371/Posology 1

    AL-60371/Posology 2

    Arm Description

    AL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes

    AL-60371 otic suspension, single dose of 4 drops following surgical insertion of tympanostomy tubes

    Outcomes

    Primary Outcome Measures

    Maximum observed analyte plasma concentration (Cmax)
    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)
    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)
    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-∞)
    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)
    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)
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2013
    Last Updated
    March 4, 2016
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01908764
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Management Decision
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    January 2015 (Anticipated)
    Study Completion Date
    January 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Otitis Media
    Keywords
    ear tubes, tympanostomy tubes, Otitis Media at the time of Tympanostomy Tube surgery, OMTT

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AL-60371/Posology 1
    Arm Type
    Experimental
    Arm Description
    AL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes
    Arm Title
    AL-60371/Posology 2
    Arm Type
    Experimental
    Arm Description
    AL-60371 otic suspension, single dose of 4 drops following surgical insertion of tympanostomy tubes
    Intervention Type
    Drug
    Intervention Name(s)
    AL-60371 otic suspension
    Primary Outcome Measure Information:
    Title
    Maximum observed analyte plasma concentration (Cmax)
    Description
    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 Frame
    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
    Title
    Time to reach Cmax (Tmax)
    Description
    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 Frame
    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
    Title
    Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last)
    Description
    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 Frame
    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
    Title
    Area under the concentration-time curve from 0 to infinity (AUC0-∞)
    Description
    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 Frame
    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
    Title
    Time to last measurable concentration (Tlast)
    Description
    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 Frame
    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
    Title
    The terminal elimination half (T½)
    Description
    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 Frame
    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Celeste McClean, BS, MT (ASCP)
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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